GeriatricPhase 3GERIHYPONCT07019805
What Causes Low Blood Pressure After Anesthesia in Older Adults Having Non-Heart Surgery ?
A Phase 3 study testing Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam and Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug in people with Geriatric and General Anesthesia Induced Hypotension, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The purpose of this study is to identify risk factors contributing to post-induction hypotension in geriatric patients undergoing elective non-cardiac surgery under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric, General Anesthesia Induced Hypotension, Elective Surgery
- What is being tested?
- Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam and Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2024to 15 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Geriatric patients aged over 60 years undergoing elective non-cardiac surgical procedures under general anesthesia, with ASA (American Society of Anesthesiologists) classification I-IV.
Who cannot join
- Patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropic infusions before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Post-Induction Hypotension Following General Anesthesia in Geriatric Patients Undergoing Elective Non-Cardiac Surgery : A Prospective Study
The purpose of this study is to identify risk factors contributing to post-induction hypotension in geriatric patients undergoing elective non-cardiac surgery under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital. Post-induction hypotension is defined as a decrease in Mean Arterial Pressure (MAP) of more than 30% from baseline after anesthesia induction up to 20 minutes post-induction. This condition can lead to adverse effects such as myocardial injury, acute kidney injury, stroke, and even death.
This research aims to answer several key questions, including whether the following factors influence the risk of post-induction hypotension:
Read more
- Airway management with endotracheal intubation.
- Low albumin levels.
- Presence of comorbidities such as hypertension, cancer/malignancy, diabetes mellitus, chronic heart disease, and chronic kidney failure.
- Dose of propofol during anesthesia induction.
- Dose of fentanyl administered during anesthesia induction.
- Dose of midazolam administered during anesthesia induction.
- Frailty score.
This study is an observational analytical study with a prospective cohort design. Data will be collected from medical records and direct observation of geriatric patients who meet the inclusion and exclusion criteria. Sampling will be done using a consecutive sampling method. The targeted sample size is 333 subjects, accounting for a 10% dropout rate.
Study subjects will meet the inclusion criteria: geriatric patients over 60 years old undergoing elective non-cardiac surgery under general anesthesia with ASA (American Society of Anesthesiologists) classification I-IV. Exclusion criteria include patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropics before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
The data to be recorded include patient characteristics, ASA classification, history of comorbidities, medications consumed, vital signs (before entering the operating room, upon arrival in the operating room, immediately after intubation, and at 5, 10, 15, and 20 minutes after intubation), type of surgery, anesthesia technique, type of anesthetic gas used, total doses of propofol, fentanyl, and midazolam with their administration times, laboratory results, chest X-ray results, presence or absence of endotracheal intubation procedure, administration of vasopressors or inotropics before induction, and patient position during blood pressure measurements. Data analysis will be performed using Graphpad Prism version 10 for MacOS, including descriptive analysis, normality tests, bivariate tests (Chi-square or Fisher's exact test, T-test or Mann-Whitney), and multivariate analysis using Cox regression to identify risk factors and determine relative risk.
Read the detailed description
Research Title: Risk Factors for Post-Induction Hypotension in Geriatric Patients Undergoing Elective Non-Cardiac Surgery Under General Anesthesia
Researcher: Dr. dr. Aida Rosita Tantri, Sp.An-TI, Subsp.An.R (K)
Institution: Department of Anesthesiology and Intensive Therapy, Faculty of Medicine, University of Indonesia, Jakarta, 2024
Background:
General anesthesia aims to achieve the anesthetic triad: loss of consciousness, loss of pain, and skeletal muscle relaxation. However, general anesthesia can also cause adverse effects, one of which is hemodynamic instability like hypotension. Hypotension is the most commonly encountered hemodynamic disturbance and can occur immediately after the completion of general anesthesia induction until the start of surgery. Post-induction hypotension carries a risk of adverse conditions such as myocardial injury, acute kidney injury, stroke, and mortality. The definition of hypotension varies, with incidence ranging from 5-99%. Some definitions mentioned include systolic blood pressure <90 mmHg or receiving at least one norepinephrine infusion at a rate of >6 micrograms (mcg) per minute within 20 minutes post-induction (Südfeld et al.), as well as a decrease in Mean Arterial Pressure (MAP) of more than 30% compared to baseline or initial data (Jor et al. and Bijker et al.). Perioperative morbidity is more frequent in the geriatric age group, making increasing age one of the predictive factors for post-induction hypotension. Other risk factors that have been studied include hypertension upon arrival in the operating room, increased fentanyl dosage, induction with propofol, and the degree of frailty. By understanding these risk factors, it is hoped that complications from post-induction hypotension can be prevented.
Problem Statement:
Post-induction hypotension in general anesthesia, characterized by a decrease in MAP >30% compared to baseline MAP, is a common complication with extensively described negative effects. Although various factors have been studied to predict the occurrence of post-anesthesia hypotension, specific studies on geriatric patients undergoing elective non-cardiac surgery under general anesthesia have not yet been conducted in Indonesia, particularly at Dr. Cipto Mangunkusumo National Central Public Hospital.
Research Questions:
- Does airway management with endotracheal intubation affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does a low albumin level affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the presence of comorbid diseases (hypertension, cancer/malignancy, diabetes mellitus, chronic heart disease, chronic kidney failure) affect the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the dose of propofol during anesthesia induction affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the dose of fentanyl administered during anesthesia induction affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the dose of midazolam administered during anesthesia induction affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the frailty score affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
Research Hypotheses:
- Airway management with endotracheal intubation affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- Low albumin levels affect the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The presence of comorbid diseases (hypertension, dyslipidemia, cancer, diabetes mellitus, chronic heart disease, chronic kidney failure) affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The dose of propofol during induction affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The dose of fentanyl during induction affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The dose of midazolam during induction affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The frailty score affects the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
Research Objectives:
- General Objective: To identify risk factors for post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital.
- Specific Objectives:
- To analyze the relationship between airway management and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between albumin levels and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between comorbid diseases and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between propofol dose during induction and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between fentanyl dose and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between midazolam dose and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between frailty score and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
Research Benefits:
The results of this study are expected to provide useful information for researchers, educational institutions, and public services. By identifying risk factors for post-induction hypotension, it is hoped that this can serve as a basis for prevention efforts, minimization, and appropriate management of the negative effects of post-induction hypotension, especially for the geriatric population undergoing general anesthesia. For educational institutions, this research will add information and knowledge to predict and minimize the negative effects of post-induction hypotension. For the community, it is expected to provide information and education about risk factors for post-induction hypotension, especially for geriatrics undergoing surgery with general anesthesia. For researchers, these results can serve as a basis and reference for further research development, as well as contribute knowledge on risk factors for post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
Research Methodology:
- Research Design: Observational analytic study with a prospective cohort design.
- Location and Time of Research: Kanigara and Kirana operating theaters at Dr. Cipto Mangunkusumo National Central Public Hospital, estimated to be from September 2024 to March 2025.
- Population and Sample:
Target Population: All geriatric patients undergoing elective non-cardiac surgical procedures under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital.
- Inclusion Criteria: Geriatric patients aged over 60 years undergoing elective non-cardiac surgical procedures under general anesthesia, with ASA (American Society of Anesthesiologists) classification I-IV.
- Exclusion Criteria: Patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropic infusions before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
- Sample Size Estimation: Calculated using sample formulas for comparing two proportions (Jor et al., Kawasaki et al., Green et al., Lee et al. ) and a rule of thumb formula. Based on calculations using the individual factor risk formulas, the largest sample size required for each variable is 100 subjects, resulting in a total of 200 subjects for both groups. Considering a 10% dropout rate, the total sample required is 220 subjects. However, using the "rules of thumb" formula, a total sample of 303 subjects is obtained for both groups, and with a 10% dropout rate, the total sample becomes 333 subjects. Therefore, the total number of subjects in this study will be 333.
Research Procedure:
- Research Instruments: Patient data collection form (CRF) to record patient characteristics, ASA classification, history of comorbid diseases, medications consumed, vital signs (before entering the operating room, upon arrival in the operating room, immediately after intubation, and at 5, 10, 15, 20 minutes after intubation), type of surgery, anesthesia technique, type of anesthetic gas used, total doses of propofol, fentanyl, and midazolam with their administration times, laboratory results, chest X-ray results, presence or absence of endotracheal intubation procedure, administration of vasopressors or inotropics before induction, and patient position during blood pressure measurements.
- Subject Recruitment: Begins after ethical approval from KEPK FKUI - RSCM and permission from the director of Dr. Cipto Mangunkusumo National Central Public Hospital have been issued. Subjects meeting the inclusion and exclusion criteria will be used as study samples. An explanation of the study's purpose, procedures, benefits, and risks will be provided to the patient or accompanying family members, followed by the signing of an informed consent form. Sample collection will be done through consecutive sampling.
- Research Implementation: Data from medical records will be copied into the research form (CRF) and then transferred into a Microsoft Excel soft file for data tabulation.
Research Variables:
- Dependent Variable: Post-induction hypotension.
- Independent Variables: Airway management, albumin levels, comorbid diseases (hypertension, diabetes mellitus, cancer/malignancy, chronic cardiac disease, chronic kidney failure), propofol use and dose, fentanyl use and dose, and midazolam use and dose.
Operational Definition: Detailed definitions and methods of measurement for each variable (gender, age, BMI, ASA classification, post-induction hypotension, airway management, albumin levels, comorbid diseases, pulse rate, MAP before and after induction, T0, TEI, T5, T10, T15, T20, propofol dose, fentanyl dose, midazolam dose, frailty score) are presented in a table.
Data Analysis: Analysis will be performed using Graphpad Prism version 10 for MacOS. The analysis stages include descriptive analysis, normality testing (Kolmogorov Smirnov test), presentation of categorical data (counts and percentages), and numerical data (mean ± standard deviation for normally distributed data, and median (min - max) for non-normally distributed data). Bivariate analysis will use the Chi-square test or Fisher's exact test for categorical data, and the unpaired T-test or Mann-Whitney test for numerical data. Multivariate analysis will be conducted on variables with a p-value < 0.25 in bivariate analysis using Cox regression to identify determinant risk factors and determine the relative risk. A 95% confidence interval will be used, with a p-value < 0.05 considered statistically significant. Receiver operating characteristic (ROC) curves will be generated to measure the discriminative power of risk factors.
Research Ethics:
Ethical approval for the research will be obtained from the Health Research Ethics Committee of the Faculty of Medicine, University of Indonesia - Dr. Cipto Mangunkusumo National Central Public Hospital. Once ethical approval and research site permits are issued, the research can commence, adhering to ethical principles: autonomy (informed consent from subjects after receiving information on objectives, procedures, benefits, and risks, ensuring confidentiality), justice (subjects will undergo anesthesia as planned, with no changes in technique, and data will only be collected from medical records), beneficence (researchers will ensure subject benefit and comfort during the study), and non-maleficence (transparent reporting to the ethics committee in case of incidents or undesirable events).
- Conditions
- Geriatric, General Anesthesia Induced Hypotension, Elective Surgery, Hypotension, Risk Factor
- Being tested
- Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam, Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug
- Keywords
- Geriatric, Hypotension, General Anesthesia, Risk Factor
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard General Anesthesia Induction Using Propofol, Fentanyl and MidazolamDrug
This intervention refers to the standard induction of general anesthesia in geriatric patients undergoing elective non-cardiac surgery. Induction typically involves the administration of intravenous anesthetic agents such as propofol and fentanyl, based on institutional protocols and the anesthesiologist's discretion. This study does not modify or introduce any new treatment; it merely observes and records peri-induction parameters to identify factors associated with the occurrence of post-induction hypotension.
Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drugDevice
This intervention involves the standard clinical use of non-invasive continuous blood pressure monitoring during the induction of general anesthesia in geriatric patients undergoing elective non-cardiac surgery. Intravenous anesthetic agents (e.g., propofol, fentanyl) and vasopressors (e.g., ephedrine, norepinephrine) are administered via syringe pumps based on the anesthesiologist's clinical judgment. The study does not introduce any experimental treatment but observes blood pressure changes in real time to identify risk factors for post-induction hypotension. The integration of continuous hemodynamic monitoring distinguishes this observational approach from routine anesthetic induction without such monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery | Other | This arm includes geriatric patients (aged 60 years and older) undergoing elective non-cardiac surgery under general anesthesia. The study will observe and record the occurrence of post-induction hypotension and evaluate various patient-related and anesthesia-related risk factors that may contribute to its development. No experimental intervention will be administered as this is an observational study. Receives: Drug: Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam; Device: Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Pre-Induction Risk Factors and Post-Induction Hypotension
Hypotension is defined as a decrease in mean arterial pressure (MAP) of more than 20% from baseline or MAP < 65 mmHg within 10 minutes after induction. The study will record the presence or absence of hypotension in each participant.
Measured: Baseline to 20 minutes post-induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Sep 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GeriatricStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019805
- Sponsor's protocol ID
- 24-08-1341
- Acronym
- GERIHYPO
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data collected through this study will be kept confidential. The identity of each respondent will be presented only as initials and can only be accessed by the research team and the health research ethics committee for verification purposes. Presentation of the research results at scientific meetings or in any form of scientific publication will not include your name or any personal identifying information.
Publications
Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
PubMed 16115962Sutthibenjakul K, Chatmongkolchart S. Risk factors for postinduction hypotension among elderly patients undergoing elective non-cardiac surgery under general anesthesia. Journal of Health Science and Medical Research. 2021;39(5).
Lim BG, Lee IO. Anesthetic management of geriatric patients. Korean J Anesthesiol. 2020 Feb;73(1):8-29. doi: 10.4097/kja.19391. Epub 2019 Oct 22.
PubMed 31636241Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.
PubMed 30027443Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.
PubMed 22277949de la Hoz MA, Rangasamy V, Bastos AB, Xu X, Novack V, Saugel B, Subramaniam B. Intraoperative Hypotension and Acute Kidney Injury, Stroke, and Mortality during and outside Cardiopulmonary Bypass: A Retrospective Observational Cohort Study. Anesthesiology. 2022 Jun 1;136(6):927-939. doi: 10.1097/ALN.0000000000004175.
PubMed 35188970Mangku G, Senaphati TGA. Buku ajar ilmu anastesia dan reanimasi. PT Indeks. 2010.
Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
PubMed 28974066
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Post-Induction Hypotension Following General Anesthesia in Geriatric Patients Undergoing Elective Non-Cardiac Surgery : A Prospective Study
- ClinicalTrials.gov ID
- NCT07019805
- Acronym / sponsor ID
- GERIHYPO / 24-08-1341
- Conditions
- Geriatric, General Anesthesia Induced Hypotension, Elective Surgery, Hypotension, Risk Factor
- Keywords
- Geriatric, Hypotension, General Anesthesia, Risk Factor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify risk factors contributing to post-induction hypotension in geriatric patients undergoing elective non-cardiac surgery under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital. Post-induction hypotension is defined as a decrease in Mean Arterial Pressure (MAP) of more than 30% from baseline after anesthesia induction up to 20 minutes post-induction. This condition can lead to adverse effects such as myocardial injury, acute kidney injury, stroke, and even death.
This research aims to answer several key questions, including whether the following factors influence the risk of post-induction hypotension:
- Airway management with endotracheal intubation.
- Low albumin levels.
- Presence of comorbidities such as hypertension, cancer/malignancy, diabetes mellitus, chronic heart disease, and chronic kidney failure.
- Dose of propofol during anesthesia induction.
- Dose of fentanyl administered during anesthesia induction.
- Dose of midazolam administered during anesthesia induction.
- Frailty score.
This study is an observational analytical study with a prospective cohort design. Data will be collected from medical records and direct observation of geriatric patients who meet the inclusion and exclusion criteria. Sampling will be done using a consecutive sampling method. The targeted sample size is 333 subjects, accounting for a 10% dropout rate.
Study subjects will meet the inclusion criteria: geriatric patients over 60 years old undergoing elective non-cardiac surgery under general anesthesia with ASA (American Society of Anesthesiologists) classification I-IV. Exclusion criteria include patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropics before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
The data to be recorded include patient characteristics, ASA classification, history of comorbidities, medications consumed, vital signs (before entering the operating room, upon arrival in the operating room, immediately after intubation, and at 5, 10, 15, and 20 minutes after intubation), type of surgery, anesthesia technique, type of anesthetic gas used, total doses of propofol, fentanyl, and midazolam with their administration times, laboratory results, chest X-ray results, presence or absence of endotracheal intubation procedure, administration of vasopressors or inotropics before induction, and patient position during blood pressure measurements. Data analysis will be performed using Graphpad Prism version 10 for MacOS, including descriptive analysis, normality tests, bivariate tests (Chi-square or Fisher's exact test, T-test or Mann-Whitney), and multivariate analysis using Cox regression to identify risk factors and determine relative risk.
Detailed description
Research Title: Risk Factors for Post-Induction Hypotension in Geriatric Patients Undergoing Elective Non-Cardiac Surgery Under General Anesthesia
Researcher: Dr. dr. Aida Rosita Tantri, Sp.An-TI, Subsp.An.R (K)
Institution: Department of Anesthesiology and Intensive Therapy, Faculty of Medicine, University of Indonesia, Jakarta, 2024
Background:
General anesthesia aims to achieve the anesthetic triad: loss of consciousness, loss of pain, and skeletal muscle relaxation. However, general anesthesia can also cause adverse effects, one of which is hemodynamic instability like hypotension. Hypotension is the most commonly encountered hemodynamic disturbance and can occur immediately after the completion of general anesthesia induction until the start of surgery. Post-induction hypotension carries a risk of adverse conditions such as myocardial injury, acute kidney injury, stroke, and mortality. The definition of hypotension varies, with incidence ranging from 5-99%. Some definitions mentioned include systolic blood pressure <90 mmHg or receiving at least one norepinephrine infusion at a rate of >6 micrograms (mcg) per minute within 20 minutes post-induction (Südfeld et al.), as well as a decrease in Mean Arterial Pressure (MAP) of more than 30% compared to baseline or initial data (Jor et al. and Bijker et al.). Perioperative morbidity is more frequent in the geriatric age group, making increasing age one of the predictive factors for post-induction hypotension. Other risk factors that have been studied include hypertension upon arrival in the operating room, increased fentanyl dosage, induction with propofol, and the degree of frailty. By understanding these risk factors, it is hoped that complications from post-induction hypotension can be prevented.
Problem Statement:
Post-induction hypotension in general anesthesia, characterized by a decrease in MAP >30% compared to baseline MAP, is a common complication with extensively described negative effects. Although various factors have been studied to predict the occurrence of post-anesthesia hypotension, specific studies on geriatric patients undergoing elective non-cardiac surgery under general anesthesia have not yet been conducted in Indonesia, particularly at Dr. Cipto Mangunkusumo National Central Public Hospital.
Research Questions:
- Does airway management with endotracheal intubation affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does a low albumin level affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the presence of comorbid diseases (hypertension, cancer/malignancy, diabetes mellitus, chronic heart disease, chronic kidney failure) affect the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the dose of propofol during anesthesia induction affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the dose of fentanyl administered during anesthesia induction affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the dose of midazolam administered during anesthesia induction affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
- Does the frailty score affect the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery?
Research Hypotheses:
- Airway management with endotracheal intubation affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- Low albumin levels affect the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The presence of comorbid diseases (hypertension, dyslipidemia, cancer, diabetes mellitus, chronic heart disease, chronic kidney failure) affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The dose of propofol during induction affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The dose of fentanyl during induction affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The dose of midazolam during induction affects the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
- The frailty score affects the risk of post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
Research Objectives:
- General Objective: To identify risk factors for post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital.
- Specific Objectives:
- To analyze the relationship between airway management and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between albumin levels and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between comorbid diseases and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between propofol dose during induction and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between fentanyl dose and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between midazolam dose and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
- To analyze the relationship between frailty score and the incidence of post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia.
Research Benefits:
The results of this study are expected to provide useful information for researchers, educational institutions, and public services. By identifying risk factors for post-induction hypotension, it is hoped that this can serve as a basis for prevention efforts, minimization, and appropriate management of the negative effects of post-induction hypotension, especially for the geriatric population undergoing general anesthesia. For educational institutions, this research will add information and knowledge to predict and minimize the negative effects of post-induction hypotension. For the community, it is expected to provide information and education about risk factors for post-induction hypotension, especially for geriatrics undergoing surgery with general anesthesia. For researchers, these results can serve as a basis and reference for further research development, as well as contribute knowledge on risk factors for post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
Research Methodology:
- Research Design: Observational analytic study with a prospective cohort design.
- Location and Time of Research: Kanigara and Kirana operating theaters at Dr. Cipto Mangunkusumo National Central Public Hospital, estimated to be from September 2024 to March 2025.
- Population and Sample:
Target Population: All geriatric patients undergoing elective non-cardiac surgical procedures under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital.
- Inclusion Criteria: Geriatric patients aged over 60 years undergoing elective non-cardiac surgical procedures under general anesthesia, with ASA (American Society of Anesthesiologists) classification I-IV.
- Exclusion Criteria: Patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropic infusions before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
- Sample Size Estimation: Calculated using sample formulas for comparing two proportions (Jor et al., Kawasaki et al., Green et al., Lee et al. ) and a rule of thumb formula. Based on calculations using the individual factor risk formulas, the largest sample size required for each variable is 100 subjects, resulting in a total of 200 subjects for both groups. Considering a 10% dropout rate, the total sample required is 220 subjects. However, using the "rules of thumb" formula, a total sample of 303 subjects is obtained for both groups, and with a 10% dropout rate, the total sample becomes 333 subjects. Therefore, the total number of subjects in this study will be 333.
Research Procedure:
- Research Instruments: Patient data collection form (CRF) to record patient characteristics, ASA classification, history of comorbid diseases, medications consumed, vital signs (before entering the operating room, upon arrival in the operating room, immediately after intubation, and at 5, 10, 15, 20 minutes after intubation), type of surgery, anesthesia technique, type of anesthetic gas used, total doses of propofol, fentanyl, and midazolam with their administration times, laboratory results, chest X-ray results, presence or absence of endotracheal intubation procedure, administration of vasopressors or inotropics before induction, and patient position during blood pressure measurements.
- Subject Recruitment: Begins after ethical approval from KEPK FKUI - RSCM and permission from the director of Dr. Cipto Mangunkusumo National Central Public Hospital have been issued. Subjects meeting the inclusion and exclusion criteria will be used as study samples. An explanation of the study's purpose, procedures, benefits, and risks will be provided to the patient or accompanying family members, followed by the signing of an informed consent form. Sample collection will be done through consecutive sampling.
- Research Implementation: Data from medical records will be copied into the research form (CRF) and then transferred into a Microsoft Excel soft file for data tabulation.
Research Variables:
- Dependent Variable: Post-induction hypotension.
- Independent Variables: Airway management, albumin levels, comorbid diseases (hypertension, diabetes mellitus, cancer/malignancy, chronic cardiac disease, chronic kidney failure), propofol use and dose, fentanyl use and dose, and midazolam use and dose.
Operational Definition: Detailed definitions and methods of measurement for each variable (gender, age, BMI, ASA classification, post-induction hypotension, airway management, albumin levels, comorbid diseases, pulse rate, MAP before and after induction, T0, TEI, T5, T10, T15, T20, propofol dose, fentanyl dose, midazolam dose, frailty score) are presented in a table.
Data Analysis: Analysis will be performed using Graphpad Prism version 10 for MacOS. The analysis stages include descriptive analysis, normality testing (Kolmogorov Smirnov test), presentation of categorical data (counts and percentages), and numerical data (mean ± standard deviation for normally distributed data, and median (min - max) for non-normally distributed data). Bivariate analysis will use the Chi-square test or Fisher's exact test for categorical data, and the unpaired T-test or Mann-Whitney test for numerical data. Multivariate analysis will be conducted on variables with a p-value < 0.25 in bivariate analysis using Cox regression to identify determinant risk factors and determine the relative risk. A 95% confidence interval will be used, with a p-value < 0.05 considered statistically significant. Receiver operating characteristic (ROC) curves will be generated to measure the discriminative power of risk factors.
Research Ethics:
Ethical approval for the research will be obtained from the Health Research Ethics Committee of the Faculty of Medicine, University of Indonesia - Dr. Cipto Mangunkusumo National Central Public Hospital. Once ethical approval and research site permits are issued, the research can commence, adhering to ethical principles: autonomy (informed consent from subjects after receiving information on objectives, procedures, benefits, and risks, ensuring confidentiality), justice (subjects will undergo anesthesia as planned, with no changes in technique, and data will only be collected from medical records), beneficence (researchers will ensure subject benefit and comfort during the study), and non-maleficence (transparent reporting to the ethics committee in case of incidents or undesirable events).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery | Other | Drug: Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam, Device: Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drugThis arm includes geriatric patients (aged 60 years and older) undergoing elective non-cardiac surgery under general anesthesia. The study will observe and record the occurrence of post-induction hypotension and evaluate various patient-related and anesthesia-related risk factors that may contribute to its development. No experimental intervention will be administered as this is an observational study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Geriatric patients aged over 60 years undergoing elective non-cardiac surgical procedures under general anesthesia, with ASA (American Society of Anesthesiologists) classification I-IV.
Key exclusion criteria (1 listed)
- Patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropic infusions before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard General Anesthesia Induction Using Propofol, Fentanyl and MidazolamThis intervention refers to the standard induction of general anesthesia in geriatric patients undergoing elective non-cardiac surgery. Induction typically involves the administration of intravenous anesthetic agents such as propofol and fentanyl, based on institutional protocols and the anesthesiologist's discretion. This study does not modify or introduce any new treatment; it merely observes and records peri-induction parameters to identify factors associated with the occurrence of post-induction hypotension. | Drug | Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery |
| Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drugThis intervention involves the standard clinical use of non-invasive continuous blood pressure monitoring during the induction of general anesthesia in geriatric patients undergoing elective non-cardiac surgery. Intravenous anesthetic agents (e.g., propofol, fentanyl) and vasopressors (e.g., ephedrine, norepinephrine) are administered via syringe pumps based on the anesthesiologist's clinical judgment. The study does not introduce any experimental treatment but observes blood pressure changes in real time to identify risk factors for post-induction hypotension. The integration of continuous hemodynamic monitoring distinguishes this observational approach from routine anesthetic induction without such monitoring. | Device | Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery |
Primary outcome
Association Between Pre-Induction Risk Factors and Post-Induction Hypotension
Time frame: Baseline to 20 minutes post-induction
Hypotension is defined as a decrease in mean arterial pressure (MAP) of more than 20% from baseline or MAP < 65 mmHg within 10 minutes after induction. The study will record the presence or absence of hypotension in each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 16115962Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
- BackgroundSutthibenjakul K, Chatmongkolchart S. Risk factors for postinduction hypotension among elderly patients undergoing elective non-cardiac surgery under general anesthesia. Journal of Health Science and Medical Research. 2021;39(5).
- Background: PubMed 31636241Lim BG, Lee IO. Anesthetic management of geriatric patients. Korean J Anesthesiol. 2020 Feb;73(1):8-29. doi: 10.4097/kja.19391. Epub 2019 Oct 22.
- Background: PubMed 30027443Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.
- Background: PubMed 22277949Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.
- Background: PubMed 35188970de la Hoz MA, Rangasamy V, Bastos AB, Xu X, Novack V, Saugel B, Subramaniam B. Intraoperative Hypotension and Acute Kidney Injury, Stroke, and Mortality during and outside Cardiopulmonary Bypass: A Retrospective Observational Cohort Study. Anesthesiology. 2022 Jun 1;136(6):927-939. doi: 10.1097/ALN.0000000000004175.
- BackgroundMangku G, Senaphati TGA. Buku ajar ilmu anastesia dan reanimasi. PT Indeks. 2010.
- Background: PubMed 28974066Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
- Individual participant dataSharing planned: No. All data collected through this study will be kept confidential. The identity of each respondent will be presented only as initials and can only be accessed by the research team and the health research ethics committee for verification purposes. Presentation of the research results at scientific meetings or in any form of scientific publication will not include your name or any personal identifying information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam and Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug in people with Geriatric and General Anesthesia Induced Hypotension, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Pre-Induction Risk Factors and Post-Induction Hypotension (time frame: Baseline to 20 minutes post-induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019805, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.