Post-induction Hypotension (PIH)NCT07294040
Incidence and Risk Factors of Post-Induction Hypotension in Geriatric Cancer Patients
An observational study of Post-induction Hypotension (PIH) and Geriatric Patient, run by Dolunay ARIK at 1 site in Turkey (Türkiye).
Trial summary
This observational clinical study aims to investigate the incidence and risk factors of post-induction hypotension (PIH) in geriatric cancer patients undergoing surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Post-induction Hypotension (PIH), Geriatric Patient, Oncologic Disease
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2025to 25 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population will consist of geriatric patients (≥65 years) undergoing oncologic surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey.
Who may be able to join
- Adults ≥65 years of age
- Patients with a diagnosis of cancer and scheduled for surgery
- Ability and willingness to provide written informed consent
- ASA physical status class II-IV
Who cannot join
- Patients under 65 years of age
- Patients without a confirmed oncologic diagnosis
- Refusal to provide written informed consent
- Patients undergoing regional anesthesia
- Patients with tracheostomy or requiring multiple intubation attempts
- History of peripheral arterial disease
Show all 10Show fewer
- Use of vasopressors before the start of surgery
- Uncontrolled hypertension (blood pressure >180/110 mmHg)
- Advanced heart failure (Ejection Fraction <40%)
- Severe arrhythmias such as atrial fibrillation or significant ventricular arrhythmias that preclude reliable hemodynamic monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Ankara, 06200
dolunay arık, +90 0554 977 44 97, arikdolunay@gmail.com
About this study
Official title: A Prospective Observational Study to Determine the Incidence and Risk Factors of Post-Induction Hypotension in Geriatric Oncologic Patients Undergoing General Anesthesia at a Tertiary Oncology Center
This observational clinical study aims to investigate the incidence and risk factors of post-induction hypotension (PIH) in geriatric cancer patients undergoing surgery under general anesthesia. PIH is defined as a drop in mean arterial pressure of ≥30% from baseline or below 65 mmHg within the first 20 minutes after anesthesia induction, prior to surgical stimulation.
The primary objective is to determine the frequency of PIH in elderly oncology patients. Secondary objectives include evaluating the association of PIH with age, ASA score, cancer type, oncological treatments (chemotherapy/radiotherapy), comorbidities, medication use, anemia, biochemical parameters, and preoperative perfusion index (PI) and pleth variability index (PVI).
Findings from this study are expected to contribute to improved perioperative management and to the development of tailored anesthesia protocols for geriatric oncology patients.
Read the detailed description
This study will be conducted as a prospective observational trial at SBÜ Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation, with the aim of evaluating the incidence and risk factors of post-induction hypotension (PIH) in geriatric oncology patients. The study will commence after institutional ethics committee approval, and written informed consent will be obtained from all participants.
Standard monitoring (ECG, non-invasive blood pressure, SpO₂) will be applied in the operating room. Pre-induction values will be recorded after a 5-minute rest period. Perfusion index (PI) and pleth variability index (PVI) will be measured using the Massimo Root® with Radical-7 monitor from the non-cannulated hand, with three consecutive readings averaged.
Demographic data (age, sex, height, weight, BMI), comorbidities, regular medications, type of malignancy, history of chemotherapy/radiotherapy, and preoperative laboratory values will be documented.
Anesthesia induction will be performed with propofol (1.5-2.5 mg/kg), fentanyl (1-2 μg/kg), lidocaine (1-1.5 mg/kg), and rocuronium (0.6 mg/kg). Maintenance will be achieved using sevoflurane (1.5-2%) or desflurane (5-6%), O₂/air mixture, and remifentanil (0.1-0.2 μg/kg/min). Drugs and doses used during induction will be recorded.
PIH is defined as hypotension occurring within the first 20 minutes after induction, prior to surgical stimulation. Criteria:
A ≥30% decrease in mean arterial pressure (MAP) compared to baseline or MAP < 65 mmHg Any interventions for hypotension (vasopressors, intravenous fluids) will be documented.
Blood pressure measurements will be obtained at six time points:
T0: Baseline, before induction T1: After induction, prior to intubation T2: 1 minute after intubation T3: 5 minutes after intubation T4: 10 minutes after intubation T5: 15 minutes after intubation
The study will be completed after the T5 measurement, covering the first ~20 minutes following anesthesia induction.
In this study, post-induction hypotension (PIH) will be defined as either a ≥30% decrease in mean arterial pressure (MAP) compared to the pre-induction baseline value, or MAP < 65 mmHg. The pre-induction MAP measured non-invasively will be taken as the baseline. During the first 20 minutes after induction (measured every 2 minutes), patients meeting either criterion will be classified into the "PIH present" group, while those without such changes will be classified as "PIH absent."
Sample size calculations were performed using G*Power 3.1:
For group comparisons: Assuming a medium effect size (Cohen's d = 0.5), 80% power, and α = 0.05, 64 patients per group (128 total) are required.
For categorical variables: With a medium effect size (Cohen's w = 0.3), 108 participants are required.
For logistic regression: Based on literature, the incidence of PIH was estimated at 20%. Assuming an Odds Ratio (OR) of 2.0, a two-tailed test with 80% power and α = 0.05 indicated that at least 113 participants are needed.
All statistical analyses will be conducted using SPSS or equivalent software, with a significance threshold of p < 0.05.
- Conditions
- Post-induction Hypotension (PIH), Geriatric Patient, Oncologic Disease, Hemodynamic Effects of General Anesthesia, Risk Factors Associated With Anesthesia-Induced Hypotension
- Keywords
- Post-induction Hypotension, Perfusion Index (PI), Pleth Variability Index (PVI), geriatric patient, Oncologic Patients, General Anesthesia, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Oncologic Patients Monitored for Post-Induction Blood Pressure | This cohort includes geriatric patients (≥65 years) with a confirmed cancer diagnosis who are scheduled for surgery under general anesthesia. The focus of the study is on monitoring and evaluating post-induction blood pressure changes. Standard non-invasive monitoring (ECG, NIBP, SpO₂) will be applied, and blood pressure will be measured at predefined intervals in the first 20 minutes following anesthesia induction. The study aims to assess the frequency and determinants of post-induction hypotension in this patient population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Induction Hypotension (PIH) in Geriatric Oncologic Patients
PIH defined as ≥30% decrease from pre-induction MAP or MAP < 65 mmHg at any measurement within the window (NIBP every 2 minutes). Outcome reported as the proportion of participants meeting PIH criteria.
Measured: From anesthesia induction to 15 minutes after intubation (≈ first 20 minutes post-induction)
Secondary outcomes (1)
Association of Demographic, Oncologic, and Anesthetic Factors With Post-Induction Hypotension
Secondary objectives include evaluating the relationship between PIH and patient characteristics such as age, ASA classification, cancer diagnosis, type of oncologic treatments received, comorbidities, regular medication use, preoperative anemia, selected biochemical parameters, perfusion index (PI) and pleth variability index (PVI) measurements, as well as the anesthetic induction method.
Measured: From preoperative assessment to 20 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start25 May 2025
- Primary completion25 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-induction Hypotension (PIH)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dolunay ARIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dolunay ARIK, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294040
- Sponsor's protocol ID
- 2025-05/70
- Status last verified
- May 2025
- First submitted
- 7 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Individual data sharing
- No: No plan to share IPD publicly. Interested researchers may contact the principal investigator for data access
Publications
Phillips AT, Deiner S, Mo Lin H, Andreopoulos E, Silverstein J, Levin MA. Propofol Use in the Elderly Population: Prevalence of Overdose and Association With 30-Day Mortality. Clin Ther. 2015 Dec 1;37(12):2676-85. doi: 10.1016/j.clinthera.2015.10.005. Epub 2015 Nov 6.
PubMed 26548320Sudfeld 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 28974066Bloom MW, Hamo CE, Cardinale D, Ky B, Nohria A, Baer L, Skopicki H, Lenihan DJ, Gheorghiade M, Lyon AR, Butler J. Cancer Therapy-Related Cardiac Dysfunction and Heart Failure: Part 1: Definitions, Pathophysiology, Risk Factors, and Imaging. Circ Heart Fail. 2016 Jan;9(1):e002661. doi: 10.1161/CIRCHEARTFAILURE.115.002661.
PubMed 26747861Levin MA, Fischer GW, Lin HM, McCormick PJ, Krol M, Reich DL. Intraoperative arterial blood pressure lability is associated with improved 30 day survival. Br J Anaesth. 2015 Nov;115(5):716-26. doi: 10.1093/bja/aev293. Epub 2015 Sep 22.
PubMed 26395645Abebe MM, Arefayne NR, Temesgen MM, Admass BA. Incidence and predictive factors associated with hemodynamic instability among adult surgical patients in the post-anesthesia care unit, 2021: A prospective follow up study. Ann Med Surg (Lond). 2022 Jan 29;74:103321. doi: 10.1016/j.amsu.2022.103321. eCollection 2022 Feb.
PubMed 35145680
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Determine the Incidence and Risk Factors of Post-Induction Hypotension in Geriatric Oncologic Patients Undergoing General Anesthesia at a Tertiary Oncology Center
- ClinicalTrials.gov ID
- NCT07294040
- Acronym / sponsor ID
- 2025-05/70
- Conditions
- Post-induction Hypotension (PIH), Geriatric Patient, Oncologic Disease, Hemodynamic Effects of General Anesthesia, Risk Factors Associated With Anesthesia-Induced Hypotension
- Keywords
- Post-induction Hypotension, Perfusion Index (PI), Pleth Variability Index (PVI), geriatric patient, Oncologic Patients, General Anesthesia, Hemodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Dolunay ARIKUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 19 Dec 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.
This observational clinical study aims to investigate the incidence and risk factors of post-induction hypotension (PIH) in geriatric cancer patients undergoing surgery under general anesthesia. PIH is defined as a drop in mean arterial pressure of ≥30% from baseline or below 65 mmHg within the first 20 minutes after anesthesia induction, prior to surgical stimulation.
The primary objective is to determine the frequency of PIH in elderly oncology patients. Secondary objectives include evaluating the association of PIH with age, ASA score, cancer type, oncological treatments (chemotherapy/radiotherapy), comorbidities, medication use, anemia, biochemical parameters, and preoperative perfusion index (PI) and pleth variability index (PVI).
Findings from this study are expected to contribute to improved perioperative management and to the development of tailored anesthesia protocols for geriatric oncology patients.
Detailed description
This study will be conducted as a prospective observational trial at SBÜ Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation, with the aim of evaluating the incidence and risk factors of post-induction hypotension (PIH) in geriatric oncology patients. The study will commence after institutional ethics committee approval, and written informed consent will be obtained from all participants.
Standard monitoring (ECG, non-invasive blood pressure, SpO₂) will be applied in the operating room. Pre-induction values will be recorded after a 5-minute rest period. Perfusion index (PI) and pleth variability index (PVI) will be measured using the Massimo Root® with Radical-7 monitor from the non-cannulated hand, with three consecutive readings averaged.
Demographic data (age, sex, height, weight, BMI), comorbidities, regular medications, type of malignancy, history of chemotherapy/radiotherapy, and preoperative laboratory values will be documented.
Anesthesia induction will be performed with propofol (1.5-2.5 mg/kg), fentanyl (1-2 μg/kg), lidocaine (1-1.5 mg/kg), and rocuronium (0.6 mg/kg). Maintenance will be achieved using sevoflurane (1.5-2%) or desflurane (5-6%), O₂/air mixture, and remifentanil (0.1-0.2 μg/kg/min). Drugs and doses used during induction will be recorded.
PIH is defined as hypotension occurring within the first 20 minutes after induction, prior to surgical stimulation. Criteria:
A ≥30% decrease in mean arterial pressure (MAP) compared to baseline or MAP < 65 mmHg Any interventions for hypotension (vasopressors, intravenous fluids) will be documented.
Blood pressure measurements will be obtained at six time points:
T0: Baseline, before induction T1: After induction, prior to intubation T2: 1 minute after intubation T3: 5 minutes after intubation T4: 10 minutes after intubation T5: 15 minutes after intubation
The study will be completed after the T5 measurement, covering the first ~20 minutes following anesthesia induction.
In this study, post-induction hypotension (PIH) will be defined as either a ≥30% decrease in mean arterial pressure (MAP) compared to the pre-induction baseline value, or MAP < 65 mmHg. The pre-induction MAP measured non-invasively will be taken as the baseline. During the first 20 minutes after induction (measured every 2 minutes), patients meeting either criterion will be classified into the "PIH present" group, while those without such changes will be classified as "PIH absent."
Sample size calculations were performed using G*Power 3.1:
For group comparisons: Assuming a medium effect size (Cohen's d = 0.5), 80% power, and α = 0.05, 64 patients per group (128 total) are required.
For categorical variables: With a medium effect size (Cohen's w = 0.3), 108 participants are required.
For logistic regression: Based on literature, the incidence of PIH was estimated at 20%. Assuming an Odds Ratio (OR) of 2.0, a two-tailed test with 80% power and α = 0.05 indicated that at least 113 participants are needed.
All statistical analyses will be conducted using SPSS or equivalent software, with a significance threshold of p < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Oncologic Patients Monitored for Post-Induction Blood Pressure | – | –This cohort includes geriatric patients (≥65 years) with a confirmed cancer diagnosis who are scheduled for surgery under general anesthesia. The focus of the study is on monitoring and evaluating post-induction blood pressure changes. Standard non-invasive monitoring (ECG, NIBP, SpO₂) will be applied, and blood pressure will be measured at predefined intervals in the first 20 minutes following anesthesia induction. The study aims to assess the frequency and determinants of post-induction hypotension in this patient population. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will consist of geriatric patients (≥65 years) undergoing oncologic surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey.
Key inclusion criteria (4 listed)
- Adults ≥65 years of age
- Patients with a diagnosis of cancer and scheduled for surgery
- Ability and willingness to provide written informed consent
- ASA physical status class II-IV
Key exclusion criteria (10 listed)
- Patients under 65 years of age
- Patients without a confirmed oncologic diagnosis
- Refusal to provide written informed consent
- Patients undergoing regional anesthesia
- Patients with tracheostomy or requiring multiple intubation attempts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Post-Induction Hypotension (PIH) in Geriatric Oncologic Patients
Time frame: From anesthesia induction to 15 minutes after intubation (≈ first 20 minutes post-induction)
PIH defined as ≥30% decrease from pre-induction MAP or MAP < 65 mmHg at any measurement within the window (NIBP every 2 minutes). Outcome reported as the proportion of participants meeting PIH criteria.
1 secondary outcome
Association of Demographic, Oncologic, and Anesthetic Factors With Post-Induction Hypotension
Time frame: From preoperative assessment to 20 minutes after anesthesia induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 26548320Phillips AT, Deiner S, Mo Lin H, Andreopoulos E, Silverstein J, Levin MA. Propofol Use in the Elderly Population: Prevalence of Overdose and Association With 30-Day Mortality. Clin Ther. 2015 Dec 1;37(12):2676-85. doi: 10.1016/j.clinthera.2015.10.005. Epub 2015 Nov 6.
- 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.
- Background: PubMed 26747861Bloom MW, Hamo CE, Cardinale D, Ky B, Nohria A, Baer L, Skopicki H, Lenihan DJ, Gheorghiade M, Lyon AR, Butler J. Cancer Therapy-Related Cardiac Dysfunction and Heart Failure: Part 1: Definitions, Pathophysiology, Risk Factors, and Imaging. Circ Heart Fail. 2016 Jan;9(1):e002661. doi: 10.1161/CIRCHEARTFAILURE.115.002661.
- Background: PubMed 26395645Levin MA, Fischer GW, Lin HM, McCormick PJ, Krol M, Reich DL. Intraoperative arterial blood pressure lability is associated with improved 30 day survival. Br J Anaesth. 2015 Nov;115(5):716-26. doi: 10.1093/bja/aev293. Epub 2015 Sep 22.
- Background: PubMed 35145680Abebe MM, Arefayne NR, Temesgen MM, Admass BA. Incidence and predictive factors associated with hemodynamic instability among adult surgical patients in the post-anesthesia care unit, 2021: A prospective follow up study. Ann Med Surg (Lond). 2022 Jan 29;74:103321. doi: 10.1016/j.amsu.2022.103321. eCollection 2022 Feb.
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital mail adressLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share IPD publicly. Interested researchers may contact the principal investigator for data access
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-induction Hypotension (PIH) and Geriatric Patient, run by Dolunay ARIK at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Dec 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 Turkey (Türkiye). 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dolunay arık (+90 0554 977 44 97, arikdolunay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Induction Hypotension (PIH) in Geriatric Oncologic Patients (time frame: From anesthesia induction to 15 minutes after intubation (≈ first 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 NCT07294040, which also lists 5 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 19 Dec 2025.