| CTRI Number |
CTRI/2025/01/079607 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of propofol and ketofol on emergence from
anesthesia in patients undergoing elective neurosurgery for brain tumours |
|
Scientific Title of Study
|
Comparison of the effect of propofol versus ketofol on emergence from
anesthesia in patients undergoing elective supratentorial craniotomy, a prospective
randomized double-blind 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. Bhavna |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
6th floor, Department of Neuro-anaesthesia, Cardiothoracic and Neurosciences Centre, All India Institute of Medical Sciences
South West
DELHI
110029
India |
| Phone |
9560957595 |
| Fax |
|
| Email |
bhavna536@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mihir Prakash Pandia |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 12, 6th floor, Department of Neuroanesthesia, Cardiothoracic and Neurosciences Centre, Ansari Nagar East
South West
DELHI
110029
India |
| Phone |
9013590548 |
| Fax |
|
| Email |
pandiamihir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavna |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
6th floor, Department of Neuroanesthesia, Cardiothoracic and Neurosciences Centre, Ansari Nagar East
South West
DELHI
110029
India |
| Phone |
9560957595 |
| Fax |
|
| Email |
bhavna536@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cardiothoracic and Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Cardiothoracic and Neurosciences Centre, Ansari Nagar East, 110029 |
| 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 Bhavna |
All India Institute of Medical Sciences |
Department of Neuroanaesthsia, Cardiothoracic and Neurosciences Centre, Ansari Nagar East, 110029
South West
DELHI |
9560957595
bhavna536@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketofol infusion for maintenance of anesthesia |
Continuous infusion, given intravenously, from start of surgery to end of surgery, at the dose of 0.3 mL/kg/hour |
| Comparator Agent |
Propofol infusion for maintenance of anesthesia |
Continuous infusion, given intravenously, from start of surgery to end of surgery, at a dose of 50-100 mcg/kg/minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II patients, patients with supratentorial tumor size less than 5 cm, posted for elective craniotomy for tumor excision
|
|
| ExclusionCriteria |
| Details |
Refusal of consent, patients who are expected to need postoperative elective ventilation having massive cerebral edema, midline shift, vascular or high-grade tumor, expected duration of anesthesia greater than eight hours, patients with preoperative GCS less than fifteen, altered sensorium or having aphasia, patients with BMI more than thirty five kg per meter square, pregnant females, patients having psychiatric illness or drug abuse, patients having aphasia, patients requiring post-operative ventilation, patients having history of allergic reactions to study drug, history of previous craniotomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time for emergence |
One point assessment at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate & mean arterial pressure, Intra-operative brain bulge, Time for extubation, Time for recovery, SOMCT in the early postoperative period, Post-operative nausea & vomiting during the early recovery period, Complications of study drugs
|
Intraoperative parameters will be recorded baseline, 5 minutes after intubation, 1 minute after pin insertion completion, 1 minute after skin incision, 1 minute after Dural opening, every 30 minutes intraoperatively, 1 minute after extubation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/02/2025 |
| 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="6"
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
|
Our study proposes a prospective RCT to compare the effects of ketofol versus propofol based anesthesia on emergence from anesthesia in patients undergoing craniotomy for supratentorial tumors. Additionally, we will also be evaluating the intraoperative hemodynamics and brain bulge in these patients and the time taken for extubation and recovery from anesthesia. This research will provide valuable information related to an optimal maintenance agent for anesthesia in patients undergoing neurosurgery.
|