- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458893
Prediction of Post-Induction Hypotension Using Plethysmographic Variability Index During Diagnostic Laryngoscopy
Prediction of Post-Induction Hypotension Using the Plethysmographic Variability Index in Patients Undergoing Diagnostic Laryngoscopy Under General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Elzem Sen, Assoc Prof
- Phone Number: +905327842151
- Email: drelzemsen@gmail.com
Study Contact Backup
- Name: Merve D Yılmaz, Dr
- Phone Number: +905454253505
- Email: mervedeniztkmn@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline before induction to 5 minutes after anesthesia induction.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elzem Sen, Assoc Prof, University of Gaziantep
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/76
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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