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Clinical Trials/CTRI/2024/10/075658
CTRI/2024/10/075658RecruitingNot Applicable

Correlation between perfusion index and Bispectral index for depth of anaesthesia monitoring in adult patients undergoing elective surgery under General Anaesthesia: An Observational Study

Dr Roshan Andleeb1 site in 1 country40 target enrollmentStarted: October 28, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To determine the correlation between perfusion index (PI) and Bispectral Index (BIS) during anaesthesia, and to compare the predictive accuracy of PI and BIS for anaesthesia depth monitoring

Study Overview

Brief Summary

The BiSpectral Index (BiS) is commonly used to monitor the depth of anaesthesia. The Perfusion Index (PI), a non-invasive measure of peripheral perfusion available in modern pulse oximeters, has been studied as a potential alternative for anaesthesia depth monitoring. This study aims to evaluate PI’s validity as a substitute for BiS in adult patients during general anaesthesia.  In this study, forty ASA I-II patients, aged 18-50 years of either gender, undergoing elective surgery under general anaesthesia will be recruited. Only surgical procedures with short operative durations, minimal tissue trauma, and minimal intraoperative fluid shifts will be included. General anaesthesia will be administered as per protocol. The perfusion index and BiSpectral index will be recorded simultaneously at different timestamps during the intraoperative period (before induction, after induction, after intubation, at the start of surgery, and then every 30 minutes during the surgery, at the end of the surgery, at the cessation of anaesthesia and emergence, and lastly, after extubation). The correlation between BIS and PI will be assessed using the Pearson correlation coefficient, and the predictive value of PI concerning the depth of anaesthesia will be evaluated using the ROC curve and its corresponding Area Under the Curve (AUC) analysis.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA I-II patients of either sex
  • Age 18-50 years
  • Patients undergoing elective surgery under general anaesthesia.
  • Surgical procedures with short operative times, minimal tissue trauma, and minimal intraoperative fluid shift
  • body mass index (BMI) 18–39 kg/m2.

Exclusion Criteria

  • Patients with allergies to anaesthesia drugs
  • Patient with peripheral vascular disease, significant cardiac, renal, pulmonary, hepatic, neurological and cerebrovascular disease.
  • Patients with a history of brain injury
  • Patients on psychiatric medication.

Outcomes

Primary Outcomes

To determine the correlation between perfusion index (PI) and Bispectral Index (BIS) during anaesthesia, and to compare the predictive accuracy of PI and BIS for anaesthesia depth monitoring

Time Frame: intraoperative period

Secondary Outcomes

  • To evaluate the association between PI and hemodynamic parameters during anaesthesia.(To evaluate the correlation between PI and the MAC value during anaesthesia)

Investigators

Sponsor
Dr Roshan Andleeb
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Roshan Andleeb

AIIMS Kalyani

Study Sites (1)

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