Anesthesia Induced HypotensionNCT06589674
Comparison of Pleth Variability Index vs. Diastolic Shock Index for Predicting Hypotension During Anesthesia Induction
An observational study of Anesthesia Induced Hypotension and Hypotension Drug-Induced, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explore the frequent occurrence of hypotension during anesthesia induction due to anesthetic drugs or fasting. Predicting this condition is important for patient safety and anesthesia management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Induced Hypotension, Hypotension Drug-Induced
- What is being tested?
- Pulse variability index measurement and Diastolic shock index
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2024to 15 Mar 2025
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo elective lumbar spine surgery in Kocaeli City Hospital operating rooms constitute the study universe.
Who may be able to join
- Patients with a preoperative fasting period of at least 6 hours
- Patients scheduled for elective surgery under general anesthesia
- Patients aged 18-65 with ASA classification I-III
- Patients undergoing lumbar spinal surgery
Who cannot join
- Patients who do not agree to participate in the study
- Emergency surgeries
- Patients who will undergo surgery under spinal anesthesia
- Patients diagnosed with autonomic neuropathy
- Patients undergoing surgery with inotropic support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Pleth Variability Index and Diastolic Shock Index in Predicting Hypotension During Anesthesia Induction
This study aims to explore the frequent occurrence of hypotension during anesthesia induction due to anesthetic drugs or fasting. Predicting this condition is important for patient safety and anesthesia management. The study examines two indices: the Pleth Variability Index (PVI), derived from pulse oximeter readings, and the Diastolic Shock Index (DSI), calculated using heart rate and diastolic blood pressure. While PVI is a well-known method, DSI has been less explored in predicting anesthesia-related hypotension. The study aims to compare the effectiveness of these two indices in forecasting hypotension during anesthesia induction.
Read the detailed description
Hypotension is frequently observed during anesthesia induction due to the effects of anesthetic drugs on hemodynamics and the requirement of a specific fasting period before surgery. Induction-related hypotension can lead to decreased tissue perfusion and, consequently, secondary organ damage. Predicting anesthesia-induced hypotension in advance contributes to better anesthesia management and patient safety (1). Induction-related hypotension is defined as arterial hypotension occurring within the first 20 minutes after anesthesia induction or until the start of the surgery. Arterial hypotension is identified when mean systolic arterial pressure (MAP) decrease > 20% or MAP <65 mmHg or when norepinephrine is administered at a dose >;6 mcg/min at least once during this period (2).
The peripheral perfusion index (PI) is a simple, cost-effective monitoring method derived from non-invasive plethysmographic data using pulse oximetry. It provides an assessment of fluid status based on respiratory changes in pulse oximeter waves, with higher PI values indicating lower arterial tone. Changes in PI are interpreted as signs of vascular tone or fluid deficit issues in patients. The ratio of the highest and lowest PI values yields the Pleth Variability Index (PVI) (3,4). PVI can be used to predict hypotension during anesthesia induction (5).
Cardiac output (CO) is calculated by multiplying systemic vascular resistance (SVR) and heart rate (HR). In septic and shock patients, CO may be low, often due to decreased SVR. The autonomic system tries to maintain CO by increasing HR in response to the reduced SVR (6). Systolic and diastolic shock indices are obtained by dividing the HR by systolic and diastolic blood pressures, respectively. The diastolic shock index has been evaluated in studies to predict vasopressor response in septic patients (7). A high shock index has been associated with early vasopressor initiation and better prognosis. However, no study has yet examined the predictive power of the diastolic shock index, which is related to sympathetic response and systemic vascular resistance, for hypotension following anesthesia induction.
Moreover, the diastolic shock index has not been compared with the more commonly used PVI in terms of their ability to predict hypotension. Therefore, our study aims to test the success of diastolic shock index and PVI measurements in predicting anesthesia-induced hypotension
- Being tested
- Pulse variability index measurement, Diastolic shock index
- Keywords
- Anesthesia Induction, Hypotension Prediction, Pleth Variability Index (PVI), Diastolic Shock Index (DSI), Hemodynamic Monitoring
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse variability index measurementDiagnostic test
Also called PVI
Peripheral perfusion index (PI) is an easy-to-implement and low-cost monitoring procedure obtained by interpreting non-invasive data obtained from pulse oximetry via plethysmography. It is a tool that allows interpretation of fluid status through changes in pulse oximetry waves caused by respiration. High perfusion indices are interpreted as low arterial tone. Changes in perfusion index are interpreted as indicators of vascular tone or fluid deficit problems in patients. The ratio of the highest and lowest PI values gives the Pleth Variability Index (PVI) (3,4). Hypotension can be predicted during anesthesia induction with PVI
Diastolic shock indexOther
Also called DSI
The Diastolic Shock Index (DSI) is a hemodynamic parameter calculated by dividing the heart rate (HR) by the diastolic blood pressure (DBP). It reflects the balance between cardiac output and systemic vascular resistance, particularly in critically ill patients. A higher DSI can indicate impaired vascular resistance and may be useful for predicting the need for vasopressor support, especially in conditions like septic shock. However, its application in predicting hypotension during anesthesia induction is still under investigation.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia Group | This group includes all study patients who underwent elective lumbar spine surgery under general anesthesia. In these patients, both PVI and DSI measurements will be performed before and during anesthesia induction. Receives: Diagnostic Test: Pulse variability index measurement; Other: Diastolic shock index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of anesthesia-induced hypotension
Anesthesia-induced hypotension is a significant drop in blood pressure that occurs during the induction or maintenance of anesthesia.Arterial hypotension was defined as systolic blood pressure (SBP) ; 90 mmHg in at least one measurement during this period or norepinephrine administered at a dose of ;6 mcg/min at lea
Measured: First 20 minutes after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Aug 2024
- Primary completion15 Feb 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Induced HypotensionStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Yuksek, Kocaeli City Hospital
- Investigators
- Ahmet Yuksek, Associate Proffessor, Study director, Kocaeli City HospitalAyse Sencan, Md, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589674
- Sponsor's protocol ID
- 2024-69
- Status last verified
- May 2025
- First submitted
- 6 Sep 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of patient data is prohibited by the institution and may be requested from the institution with appropriate request.
Publications
Ospina-Tascon GA, Teboul JL, Hernandez G, Alvarez I, Sanchez-Ortiz AI, Calderon-Tapia LE, Manzano-Nunez R, Quinones E, Madrinan-Navia HJ, Ruiz JE, Aldana JL, Bakker J. Diastolic shock index and clinical outcomes in patients with septic shock. Ann Intensive Care. 2020 Apr 16;10(1):41. doi: 10.1186/s13613-020-00658-8.
PubMed 32296976Ospina-Tascon GA, Garcia-Gallardo G, Orozco N. Using the diastolic shock index to determine when to promptly administer vasopressors in patients with septic shock. Clin Exp Emerg Med. 2022 Dec;9(4):367-369. doi: 10.15441/ceem.22.401. Epub 2022 Dec 8. No abstract available.
PubMed 36480818Rasmy I, Mohamed H, Nabil N, Abdalah S, Hasanin A, Eladawy A, Ahmed M, Mukhtar A. Evaluation of Perfusion Index as a Predictor of Vasopressor Requirement in Patients with Severe Sepsis. Shock. 2015 Dec;44(6):554-9. doi: 10.1097/SHK.0000000000000481.
PubMed 26529657Coutrot M, Dudoignon E, Joachim J, Gayat E, Vallee F, Depret F. Perfusion index: Physical principles, physiological meanings and clinical implications in anaesthesia and critical care. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100964. doi: 10.1016/j.accpm.2021.100964. Epub 2021 Oct 24.
PubMed 34687923Sudfeld 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 28974066Kim YJ, Seo JH, Lee HC, Kim HS. Pleth variability index during preoxygenation could predict anesthesia-induced hypotension: A prospective, observational study. J Clin Anesth. 2023 Nov;90:111236. doi: 10.1016/j.jclinane.2023.111236. Epub 2023 Aug 26.
PubMed 37639751
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Pleth Variability Index and Diastolic Shock Index in Predicting Hypotension During Anesthesia Induction
- ClinicalTrials.gov ID
- NCT06589674
- Acronym / sponsor ID
- 2024-69
- Keywords
- Anesthesia Induction, Hypotension Prediction, Pleth Variability Index (PVI), Diastolic Shock Index (DSI), Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 19 Sep 2024 (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 study aims to explore the frequent occurrence of hypotension during anesthesia induction due to anesthetic drugs or fasting. Predicting this condition is important for patient safety and anesthesia management. The study examines two indices: the Pleth Variability Index (PVI), derived from pulse oximeter readings, and the Diastolic Shock Index (DSI), calculated using heart rate and diastolic blood pressure. While PVI is a well-known method, DSI has been less explored in predicting anesthesia-related hypotension. The study aims to compare the effectiveness of these two indices in forecasting hypotension during anesthesia induction.
Detailed description
Hypotension is frequently observed during anesthesia induction due to the effects of anesthetic drugs on hemodynamics and the requirement of a specific fasting period before surgery. Induction-related hypotension can lead to decreased tissue perfusion and, consequently, secondary organ damage. Predicting anesthesia-induced hypotension in advance contributes to better anesthesia management and patient safety (1). Induction-related hypotension is defined as arterial hypotension occurring within the first 20 minutes after anesthesia induction or until the start of the surgery. Arterial hypotension is identified when mean systolic arterial pressure (MAP) decrease > 20% or MAP <65 mmHg or when norepinephrine is administered at a dose >;6 mcg/min at least once during this period (2).
The peripheral perfusion index (PI) is a simple, cost-effective monitoring method derived from non-invasive plethysmographic data using pulse oximetry. It provides an assessment of fluid status based on respiratory changes in pulse oximeter waves, with higher PI values indicating lower arterial tone. Changes in PI are interpreted as signs of vascular tone or fluid deficit issues in patients. The ratio of the highest and lowest PI values yields the Pleth Variability Index (PVI) (3,4). PVI can be used to predict hypotension during anesthesia induction (5).
Cardiac output (CO) is calculated by multiplying systemic vascular resistance (SVR) and heart rate (HR). In septic and shock patients, CO may be low, often due to decreased SVR. The autonomic system tries to maintain CO by increasing HR in response to the reduced SVR (6). Systolic and diastolic shock indices are obtained by dividing the HR by systolic and diastolic blood pressures, respectively. The diastolic shock index has been evaluated in studies to predict vasopressor response in septic patients (7). A high shock index has been associated with early vasopressor initiation and better prognosis. However, no study has yet examined the predictive power of the diastolic shock index, which is related to sympathetic response and systemic vascular resistance, for hypotension following anesthesia induction.
Moreover, the diastolic shock index has not been compared with the more commonly used PVI in terms of their ability to predict hypotension. Therefore, our study aims to test the success of diastolic shock index and PVI measurements in predicting anesthesia-induced hypotension
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Group | – | Diagnostic Test: Pulse variability index measurement, Other: Diastolic shock indexThis group includes all study patients who underwent elective lumbar spine surgery under general anesthesia. In these patients, both PVI and DSI measurements will be performed before and during anesthesia induction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo elective lumbar spine surgery in Kocaeli City Hospital operating rooms constitute the study universe.
Key inclusion criteria (4 listed)
- Patients with a preoperative fasting period of at least 6 hours
- Patients scheduled for elective surgery under general anesthesia
- Patients aged 18-65 with ASA classification I-III
- Patients undergoing lumbar spinal surgery
Key exclusion criteria (5 listed)
- Patients who do not agree to participate in the study
- Emergency surgeries
- Patients who will undergo surgery under spinal anesthesia
- Patients diagnosed with autonomic neuropathy
- Patients undergoing surgery with inotropic support
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 |
|---|---|---|
| Pulse variability index measurementAlso: PVIPeripheral perfusion index (PI) is an easy-to-implement and low-cost monitoring procedure obtained by interpreting non-invasive data obtained from pulse oximetry via plethysmography. It is a tool that allows interpretation of fluid status through changes in pulse oximetry waves caused by respiration. High perfusion indices are interpreted as low arterial tone. Changes in perfusion index are interpreted as indicators of vascular tone or fluid deficit problems in patients. The ratio of the highest and lowest PI values gives the Pleth Variability Index (PVI) (3,4). Hypotension can be predicted during anesthesia induction with PVI | Diagnostic test | General Anesthesia Group |
| Diastolic shock indexAlso: DSIThe Diastolic Shock Index (DSI) is a hemodynamic parameter calculated by dividing the heart rate (HR) by the diastolic blood pressure (DBP). It reflects the balance between cardiac output and systemic vascular resistance, particularly in critically ill patients. A higher DSI can indicate impaired vascular resistance and may be useful for predicting the need for vasopressor support, especially in conditions like septic shock. However, its application in predicting hypotension during anesthesia induction is still under investigation. | Other | General Anesthesia Group |
Primary outcome
Prediction of anesthesia-induced hypotension
Time frame: First 20 minutes after induction of anesthesia
Anesthesia-induced hypotension is a significant drop in blood pressure that occurs during the induction or maintenance of anesthesia.Arterial hypotension was defined as systolic blood pressure (SBP) ; 90 mmHg in at least one measurement during this period or norepinephrine administered at a dose of ;6 mcg/min at lea
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 30 May 2025.
- Background: PubMed 32296976Ospina-Tascon GA, Teboul JL, Hernandez G, Alvarez I, Sanchez-Ortiz AI, Calderon-Tapia LE, Manzano-Nunez R, Quinones E, Madrinan-Navia HJ, Ruiz JE, Aldana JL, Bakker J. Diastolic shock index and clinical outcomes in patients with septic shock. Ann Intensive Care. 2020 Apr 16;10(1):41. doi: 10.1186/s13613-020-00658-8.
- Background: PubMed 36480818Ospina-Tascon GA, Garcia-Gallardo G, Orozco N. Using the diastolic shock index to determine when to promptly administer vasopressors in patients with septic shock. Clin Exp Emerg Med. 2022 Dec;9(4):367-369. doi: 10.15441/ceem.22.401. Epub 2022 Dec 8. No abstract available.
- Background: PubMed 26529657Rasmy I, Mohamed H, Nabil N, Abdalah S, Hasanin A, Eladawy A, Ahmed M, Mukhtar A. Evaluation of Perfusion Index as a Predictor of Vasopressor Requirement in Patients with Severe Sepsis. Shock. 2015 Dec;44(6):554-9. doi: 10.1097/SHK.0000000000000481.
- Background: PubMed 34687923Coutrot M, Dudoignon E, Joachim J, Gayat E, Vallee F, Depret F. Perfusion index: Physical principles, physiological meanings and clinical implications in anaesthesia and critical care. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100964. doi: 10.1016/j.accpm.2021.100964. Epub 2021 Oct 24.
- 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 37639751Kim YJ, Seo JH, Lee HC, Kim HS. Pleth variability index during preoxygenation could predict anesthesia-induced hypotension: A prospective, observational study. J Clin Anesth. 2023 Nov;90:111236. doi: 10.1016/j.jclinane.2023.111236. Epub 2023 Aug 26.
- Individual participant dataSharing planned: No. Sharing of patient data is prohibited by the institution and may be requested from the institution with appropriate request.
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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.
Ahmet Yuksek, Associate Proffessor study director
Kocaeli City Hospital
Ayse Sencan, Md principal investigator
Kocaeli City Hospital
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 Anesthesia Induced Hypotension and Hypotension Drug-Induced, run by Kocaeli City Hospital 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 5 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 30 May 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?
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?
Prediction of anesthesia-induced hypotension (time frame: First 20 minutes after induction of anesthesia). 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 NCT06589674, which also lists 6 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 30 May 2025.