| CTRI Number |
CTRI/2025/08/093281 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of propofol infusion and dexmedetomidine infusion for maintaining sleep during anaesthesia in laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison of propofol infusion versus dexmedetomidine infusion for maintainence of general anaesthesia using bispectral index monitoring for laparoscopic 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 R Brindha |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9443247021 |
| Fax |
|
| Email |
mskbrins63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Mohamed Asiq |
| Designation |
Post Graduate Resident |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9940051899 |
| Fax |
|
| Email |
m.mohamedasiq@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Kirubanandha Variyar Medical College And Hospital,Salem,Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Chinna Seeragapadi, Salem – 636 308, Tamil Nadu, India |
| 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 M Mohamed Asiq |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
Room Number 15
Department of Anaesthesiology
Salem
Salem
TAMIL NADU |
9940051899
m.mohamedasiq@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of propofol infusion versus dexmedetomidine infusion for maintainence of general anaesthesia |
Comparison of propofol infusion versus dexmedetomidine infusion for maintainence of general anaesthesia using bispectral index monitoring for laparoscopic surgeries |
| Comparator Agent |
Dexmedetomidine Infusion for Maintainence of General Anaesthesia |
Dexmedetomidine Infusion for Maintainence of General Anaesthesia Using BIS Monitoring for Laparoscopic Surgeries |
| Comparator Agent |
Propofol Infusion for Maintainence of General Anaesthesia |
Propofol Infusion for Maintainence of General Anaesthesia Using BIS Monitoring for Laparoscopic Surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status 1 and 2
Undergoing Elective Laparoscopic Surgeries |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Age less than 18 and more than 65 years
ASA 3 and 4
Posted for Emergency Surgeries
History of Allergy to Propofol and Dexmedetomidine
Any Cardiovascular Disease including Severe Hypertension,Arrhythmias or Heart failure
Liver or Renal Dysfunction
Pregnant or Breast feeding Women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of propofol infusion and dexmedetomidine infusion in maintaining an adequate depth of anaesthesia as measured by BIS Values during Laparoscopic surgeries and to evaluate the hemodynamic stability including Heart raye,Blood Pressure and Respiratory Parameters |
From 5 mins to 2 Hours Intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the recovery time,postoperative analgesic requirements and overall patient satisfaction after surgery to monitor adverse effects and complications associated with propofol and dexmedetomidine during anaesthesia maintainence |
From 15 mins to 24 Hours Postoperatively |
|
|
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)
|
01/09/2025 |
| 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 Applicable |
| 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 Trail Comparing propofol infusion versus dexmedetomidine infusion for maintainence of general anaesthesia using bispectral index monitoring for laparoscopic surgeries to look for Hemodynamic Stability and Overall all Post Operative response of the patient |