| CTRI Number |
CTRI/2026/03/106731 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two drugs to prevent waking up during brain surgery under full anesthesia |
|
Scientific Title of Study
|
Comparative study of effect of Dexmedetomidine and Propofol on Intraoperative Awareness under general anaesthesia in Neurosurgical Patients. |
| 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 Amrita M |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia, second floor, SMSC building,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7756088858 |
| Fax |
|
| Email |
mamrita1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jui A Jadhav |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia, second floor, SMSC building,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8433660179 |
| Fax |
|
| Email |
jui.jadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jui A Jadhav |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia, second floor, SMSC building,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8433660179 |
| Fax |
|
| Email |
jui.jadhav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| 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 Amrita M |
Acharya Vinoba Bhave Rural Hospital |
Department of Anesthesia. second floor, SMSC building, Sawangi Meghe
Wardha
MAHARASHTRA |
7756088858
mamrita1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
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 |
Dexmedetomidine |
IV Dexmedetomidine (1 mcg/kg)followed by infusion at the rate of 0.5 mcg/kg/hr. |
| Comparator Agent |
Propofol |
IV Propofol (1mg/kg for 10 min) followed by infusion at the rate of 50mcg/kg/min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to give informed consent (ANNEXURE 1)
2. ASA grade I, II and III.(ANNEXURE 3)
3. Patients scheduled for elective neurosurgery under general anaesthesia
4. Patients aged between 18 and 60 years.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give informed consent
2. Patients known to have an allergy or hypersensitivity to dexmedetomidine and
propofol.
3. Surgeries exceeding 3 hours
4. Patients with a heart rate of less than 50/min.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative awareness in patients administered Dexmedetomidine will be better than Propofol. |
Assessment Wii be done at 12 hrs after surgery. Overall assessment will be done at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="2"
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
|
The study titled Comparative Study of Effect of Dexmedetomidine and Propofol on Intraoperative Awareness Under General Anaesthesia in Neurosurgical Patients aims to evaluate the effectiveness of dexmedetomidine compared with propofol in preventing intraoperative awareness during neurosurgery. Intraoperative awareness is a significant complication of general anaesthesia that may result in psychological distress such as anxiety, depression, or post-traumatic stress disorder. This prospective randomized controlled trial will be conducted in the Department of Anaesthesia at Acharya Vinoba Bhave Rural Hospital, Wardha, involving 60 adult patients aged 18 to 60 years undergoing elective neurosurgery. Participants will be randomly divided into two groups: one receiving propofol and the other dexmedetomidine as the maintenance anaesthetic agent. Depth of anaesthesia will be monitored using entropy monitoring, and postoperative awareness will be assessed using the modified Brice questionnaire. Hemodynamic parameters, recovery time, and adverse effects will also be compared. The study seeks to determine whether dexmedetomidine provides better prevention of intraoperative awareness and improved hemodynamic stability compared to propofol. |