| CTRI Number |
CTRI/2025/08/092194 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
BIS monitoring in Dexmedetomidine infusion during laproscopic surgeries to reduce sevoflurane requirement |
|
Scientific Title of Study
|
A prospective randomised controlled study utilising Bispecrtal index guidance to investigate the impact of Dexmedetomidine on Sevoflurane consumption during elective laproscopic surgeries. |
| 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 Arun Kumar |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room no:15,Department of Anaesthesiology
Vinayaka missions kirupanandha variyar medical college and hospital, chinnaseragapadi, salem
Salem
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room no:15, Department of Anaesthesiology
Vinayaka missions kirupanandha variyar medical college and hospital, chinnaseragapadi, salem
Salem
TAMIL NADU
636308
India |
| Phone |
6382660052 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshini T |
| Designation |
Post Graduate Resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room n o:15,Department of Anaesthesiology
Vinayaka missions kirupanandha variyar medical college and hospital, chinnaseragapadi, salem
Salem
TAMIL NADU
636308
India |
| Phone |
9884965164 |
| Fax |
|
| Email |
harshini.thirumoorthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions kirupanandha variyar medical college and hospital, chinnaseragapadi, salem |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Number 15, Vinayaka missions kirupanandha variyar medical college and hospital, chinnaseragapadi, salem |
| Type of Sponsor |
Private 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 HarshiniT |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU |
9884965164
harshini.thirumoorthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
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 |
| Intervention |
effect of Dexmedetomidine infusion in laproscopic surgeries |
To study the effect of Dexmedetomidine on sevoflurane consumption using BIS monitoring in laproscopic surgeries |
| Comparator Agent |
Effects of Dexmedetomidine in laproscopic surgeries |
To study the effect of Dexmedetomidine on sevoflurane consumption using BIS monitoring in laproscopic surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient giving valid informed consent
ASA 1 and ASA 2
MP 1 and MP2
Elective laproscopic surgeries
BMI- 18.5 TO 24.9 |
|
| ExclusionCriteria |
| Details |
patient refusal
ASA 3 and ASA 4
Age less than 20 and above 65
patient with ischemic and rheumatic heart disease
patients on alpha agonist, antagonist and beta blockers
allergies to medications |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Dexmedetomidine on sevoflurane requirements during elective laproscopic surgeries |
From 0 minutes of dexmedetomidine infusion till the end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of the hemodynamic parameters and thereby enabling the titration of the anesthetic agent based on BIS monitoring |
From 0 min of administration to 90 mins post administration |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/08/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a randomised controlled trial to help in evaluating the effect of dexmedetomidine infusion on sevoflurane requirement using BIS monitoring in patients undergoing elective laparoscopic procedures. |