Prediction of Post-Induction Hypotension Using Plethysmographic Variability Index During Diagnostic Laryngoscopy

NCT07458893 | Not Yet Recruiting

• 1 other identifier: 2026/76
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Post-Induction Hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline before induction to 5 minutes after anesthesia induction.

Interventions

Plethysmographic Variability Index (PVI) and Perfusion Index (PI) Monitoring DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Elzem Sen, Assoc Prof

  University of Gaziantep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elzem Sen, Assoc Prof

CONTACT

+905327842151; drelzemsen@gmail.com

Merve D Yılmaz, Dr

CONTACT

+905454253505; mervedeniztkmn@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 10, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share