Post-Induction HypotensionNCT07458893
Prediction of Post-Induction Hypotension Using Plethysmographic Variability Index During Diagnostic Laryngoscopy
An observational study of Post-Induction Hypotension, run by University of Gaziantep.
Trial summary
This prospective observational study aims to evaluate whether non-invasive hemodynamic parameters, including the plethysmographic variability index (PVI) and perfusion index (PI), can predict post-induction hypotension in patients undergoing diagnostic direct laryngoscopy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Induction Hypotension
- What is being tested?
- Plethysmographic Variability Index (PVI) and Perfusion Index (PI) Monitoring
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 10 Feb 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18-75 years with ASA physical status I-III who are scheduled to undergo elective diagnostic direct laryngoscopy under general anesthesia at the Department of Anesthesiology and Reanimation and the Department of Otorhinolaryngology of Gaziantep University Faculty of Medicine Hospital. Patients meeting the eligibility criteria and providing written informed consent will be consecutively enrolled. The study will include patients undergoing routine perioperative monitoring, and non-invasive hemodynamic parameters such as plethysmographic variability index (PVI) and perfusion index (PI) will be recorded during the peri-induction period.
Who may be able to join
- Scheduled to undergo elective direct laryngoscopy under general anesthesia Body mass index (BMI) between 18 and 40 kg/m² ASA physical status classification I-III Provision of written informed consent after being informed about the study
Who cannot join
- Severe arrhythmias Advanced heart failure Severe valvular heart disease Preoperative shock or hemodynamic instability requirement for continuous vasopressor or inotropic infusion Significant peripheral vascular disease affecting peripheral circulation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prediction of Post-Induction Hypotension Using the Plethysmographic Variability Index in Patients Undergoing Diagnostic Laryngoscopy Under General Anesthesia
This prospective observational study aims to evaluate whether non-invasive hemodynamic parameters, including the plethysmographic variability index (PVI) and perfusion index (PI), can predict post-induction hypotension in patients undergoing diagnostic direct laryngoscopy under general anesthesia. Patients aged 18-75 years with ASA physical status I-III scheduled for elective direct laryngoscopy will be included. PVI and PI values will be recorded before anesthesia induction and in the early post-induction period. The relationship between these indices and the decrease in mean arterial pressure after induction will be analyzed to determine their predictive value for hypotension.
Read the detailed description
Post-induction hypotension is a common hemodynamic complication during the early phase of general anesthesia and may lead to adverse perioperative outcomes, particularly in patients with limited physiological reserve. Early identification of patients at risk for hypotension may allow clinicians to implement preventive strategies and optimize perioperative hemodynamic management. Recently, non-invasive perfusion-related parameters derived from pulse oximetry have gained attention as potential indicators of intravascular volume status and cardiovascular responsiveness.
The plethysmographic variability index (PVI) is a dynamic parameter reflecting respiratory variations in the perfusion index and is considered a non-invasive surrogate marker of fluid responsiveness. The perfusion index (PI), which represents the ratio of pulsatile to non-pulsatile blood flow in peripheral tissues, provides information about peripheral perfusion and vascular tone. These indices are continuously and non-invasively obtained using pulse oximetry and may offer clinically useful information regarding hemodynamic status during anesthesia induction.
Direct laryngoscopy performed under general anesthesia may be associated with significant hemodynamic fluctuations during both the induction phase and airway manipulation. Identifying reliable non-invasive predictors of blood pressure reduction during this period may improve intraoperative monitoring and facilitate early intervention.
- Conditions
- Post-Induction Hypotension
- Being tested
- Plethysmographic Variability Index (PVI) and Perfusion Index (PI) Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plethysmographic Variability Index (PVI) and Perfusion Index (PI) MonitoringDevice
Non-invasive monitoring of plethysmographic variability index (PVI) and perfusion index (PI) will be performed using pulse oximetry during the peri-induction period in patients undergoing diagnostic direct laryngoscopy under general anesthesia. These parameters will be recorded before anesthesia induction and during the early post-induction phase to evaluate their association with changes in mean arterial pressure and their predictive value for post-induction hypotension.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Arterial Pressure (ΔMAP) After Anesthesia Induction and Its Association With Plethysmographic Variability Index (PVI) and Perfusion Index (PI)
The relationship between plethysmographic variability index (PVI) and perfusion index (PI) values measured during the peri-induction period and the change in mean arterial pressure (ΔMAP) after anesthesia induction will be evaluated.
Measured: From baseline before induction to 5 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 posted9 Mar 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Induction 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem SEN, University of Gaziantep
- Investigators
- Elzem Sen, Assoc Prof, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458893
- Sponsor's protocol ID
- 2026/76
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Post-Induction Hypotension Using the Plethysmographic Variability Index in Patients Undergoing Diagnostic Laryngoscopy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07458893
- Acronym / sponsor ID
- 2026/76
- Conditions
- Post-Induction Hypotension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 9 Mar 2026 (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 prospective observational study aims to evaluate whether non-invasive hemodynamic parameters, including the plethysmographic variability index (PVI) and perfusion index (PI), can predict post-induction hypotension in patients undergoing diagnostic direct laryngoscopy under general anesthesia. Patients aged 18-75 years with ASA physical status I-III scheduled for elective direct laryngoscopy will be included. PVI and PI values will be recorded before anesthesia induction and in the early post-induction period. The relationship between these indices and the decrease in mean arterial pressure after induction will be analyzed to determine their predictive value for hypotension.
Detailed description
Post-induction hypotension is a common hemodynamic complication during the early phase of general anesthesia and may lead to adverse perioperative outcomes, particularly in patients with limited physiological reserve. Early identification of patients at risk for hypotension may allow clinicians to implement preventive strategies and optimize perioperative hemodynamic management. Recently, non-invasive perfusion-related parameters derived from pulse oximetry have gained attention as potential indicators of intravascular volume status and cardiovascular responsiveness.
The plethysmographic variability index (PVI) is a dynamic parameter reflecting respiratory variations in the perfusion index and is considered a non-invasive surrogate marker of fluid responsiveness. The perfusion index (PI), which represents the ratio of pulsatile to non-pulsatile blood flow in peripheral tissues, provides information about peripheral perfusion and vascular tone. These indices are continuously and non-invasively obtained using pulse oximetry and may offer clinically useful information regarding hemodynamic status during anesthesia induction.
Direct laryngoscopy performed under general anesthesia may be associated with significant hemodynamic fluctuations during both the induction phase and airway manipulation. Identifying reliable non-invasive predictors of blood pressure reduction during this period may improve intraoperative monitoring and facilitate early intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18-75 years with ASA physical status I-III who are scheduled to undergo elective diagnostic direct laryngoscopy under general anesthesia at the Department of Anesthesiology and Reanimation and the Department of Otorhinolaryngology of Gaziantep University Faculty of Medicine Hospital. Patients meeting the eligibility criteria and providing written informed consent will be consecutively enrolled. The study will include patients undergoing routine perioperative monitoring, and non-invasive hemodynamic parameters such as plethysmographic variability index (PVI) and perfusion index (PI) will be recorded during the peri-induction period.
Key inclusion criteria (1 listed)
- Scheduled to undergo elective direct laryngoscopy under general anesthesia Body mass index (BMI) between 18 and 40 kg/m² ASA physical status classification I-III Provision of written informed consent after being informed about the study
Key exclusion criteria (1 listed)
- Severe arrhythmias Advanced heart failure Severe valvular heart disease Preoperative shock or hemodynamic instability requirement for continuous vasopressor or inotropic infusion Significant peripheral vascular disease affecting peripheral circulation
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 |
|---|---|---|
| Plethysmographic Variability Index (PVI) and Perfusion Index (PI) MonitoringNon-invasive monitoring of plethysmographic variability index (PVI) and perfusion index (PI) will be performed using pulse oximetry during the peri-induction period in patients undergoing diagnostic direct laryngoscopy under general anesthesia. These parameters will be recorded before anesthesia induction and during the early post-induction phase to evaluate their association with changes in mean arterial pressure and their predictive value for post-induction hypotension. | Device | – |
Primary outcome
Change in Mean Arterial Pressure (ΔMAP) After Anesthesia Induction and Its Association With Plethysmographic Variability Index (PVI) and Perfusion Index (PI)
Time frame: From baseline before induction to 5 minutes after anesthesia induction.
The relationship between plethysmographic variability index (PVI) and perfusion index (PI) values measured during the peri-induction period and the change in mean arterial pressure (ΔMAP) after anesthesia induction will be evaluated.
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 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Elzem Sen, Assoc Prof principal investigator
University of Gaziantep
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Induction Hypotension, run by University of Gaziantep.
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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Elzem Sen, Assoc Prof (+905327842151, drelzemsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Arterial Pressure (ΔMAP) After Anesthesia Induction and Its Association With Plethysmographic Variability Index (PVI) and Perfusion Index (PI) (time frame: From baseline before induction to 5 minutes after anesthesia induction.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.