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CTRI Number  CTRI/2024/10/075658 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate perfusion index for monitoring of depth of anaesthesia in adults. 
Scientific Title of Study   Correlation between perfusion index and Bispectral index for depth of anaesthesia monitoring in adult patients undergoing elective surgery under General Anaesthesia: An Observational Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roshan Andleeb 
Designation  Assistant professor 
Affiliation  AIIMS Kalyani 
Address  Dept. of Trauma and Emergency Medicine, AIIMS Kalyani, NH-34 connector, Basantapur, Saguna, Nadia, West Bengal

Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roshan Andleeb 
Designation  Assistant professor 
Affiliation  AIIMS Kalyani 
Address  Dept. of Trauma and Emergency Medicine, AIIMS Kalyani, NH-34 connector, Basantapur, Saguna, Nadia, West Bengal

Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roshan Andleeb 
Designation  Assistant professor 
Affiliation  AIIMS Kalyani 
Address  Dept. of Trauma and Emergency Medicine, AIIMS Kalyani, NH-34 connector, Basantapur, Saguna, Nadia, West Bengal

Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Source of Monetary or Material Support  
AIIMS kalyani, NH-34 connector, Basantapur, Saguna, Nadia, Kalyani, West Bengal,India, Pincode- 741245 
 
Primary Sponsor  
Name  Dr Roshan Andleeb 
Address  dept of Trauma and Emergency Medicine, AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, Kalyani, West Bengal,India, Pincode- 741245 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roshan Andleeb  AIIMS Kalyani  Dept of Trauma and Emergency Medicine, AIIMS Kalyani, NH-34 Connector, Basantapur, Saguna, Nadia
Nadia
WEST BENGAL 
9045292647

roshan8978@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  intervention- nil comparator- nil  After administration of general anaesthesia as per protocol, simultaneously the value of perfusion index value and BiSpecral index at different timestamps will be recorded. Edit || Delete  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. ASA I-II patients of either sex
2. Age 18-50 years
3. Patients undergoing elective surgery under general anaesthesia.
4. Surgical procedures with short operative times, minimal tissue trauma, and minimal intraoperative fluid shift
5. body mass index (BMI) 18–39 kg/m2
 
 
ExclusionCriteria 
Details  1. Patients with allergies to anaesthesia drugs
2. Patient with peripheral vascular disease, significant cardiac, renal, pulmonary, hepatic, neurological and cerebrovascular disease.
3. Patients with a history of brain injury
4. Patients on psychiatric medication


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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
 
intraoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the association between PI and hemodynamic parameters during anaesthesia.
To evaluate the correlation between PI and the MAC value during anaesthesia
To evaluate the association between PI and other parameters such as opioid usage, intraoperative fluid requirement, propofol usage, and blood loss.
 
intraoperative period 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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