| 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
|
|
|
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
|
|
|
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. |