| CTRI Number |
CTRI/2024/01/061850 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is to compare the effects of ketofol and propofol as anaesthetic induction agent in patients undergoing supratentorial surgery. |
|
Scientific Title of Study
|
Comparison of ketofol and propofol as anaesthetic induction agent in patients undergoing supratentorial surgery. |
| 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 Renu Bala |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical Care Pt. B. D. Sharma PGIMS Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8901322251 |
| Fax |
|
| Email |
neurodmrenu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diksha Gulia |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical Care Pt. B. D. Sharma PGIMS Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7357220096 |
| Fax |
|
| Email |
diksha.gulia.0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Gulia |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical Care Pt. B. D. Sharma PGIMS Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7357220096 |
| Fax |
|
| Email |
diksha.gulia.0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Pt. B D Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma University of Health Sciences PGIMS |
| Address |
Pt B D Sharma University of Health Sciences PGIMS Rohtak Haryana |
| 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 Diksha Gulia |
Pt B D Sharma PGIMS Rohtak |
Department of Anaesthesiology and Critical Care Neurology OT Lala Shyam Lal Building PGIMS Rohtak
Rohtak
HARYANA |
7357220096
diksha.gulia.0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt B D Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketofol |
Standardized anaesthesia protocol will be followed. In ketofol group drug will be prepared in 20ml syringe by adding 5ml ketamine and 15ml of propofol. Preoxygenation will be done for 3 minutes with hundred percent oxygen. Injection glycopyrrolate, midazolam & fentanyl will be given followed by induction of anaesthesia by ketofol over 10 seconds. Loss of response to verbal commands will be assessed. The dose of drug required & time taken for induction of anaesthesia will be noted. Pain on injection & myoclonus if present will be noted. Bag mask ventilation will be assessed & vecuronium will be given for neuromuscular blockade. Bag mask ventilation will continue with oxygen in sevoflurane for 3 minutes. Injection xylocard will be given 90 seconds prior to tracheal intubation. Direct laryngoscopy using Macintosh laryngoscope will be done & endotracheal intubation will be done with appropriate size PVC tube & bilateral air entry will be verified. Mechanical ventilation with appropriate settings will be done to maintain eucapnia. Vital monitoring(HR, SBP, DBP, MAP, EtCO2, SPO2, MAC) will be done continuously & recorded at baseline 1min & 2min after induction 3, 5, 10 min after intubation. Maintenance of anaesthesia will be done with sevoflurane in N2O & O2 targeting a MAC 0.8-1.2. Mannitol over 30 min fentanyl & vecuronium infusion will be administered. Surgery will commence & after opening of dura brain relaxation score will be noted. Rest of the anaesthesia and extubation process will be managed as per standard protocol. Following parameters will be noted- duration of surgery,
duration of anaesthesia,
total requirement of drug,
fluids & blood transfused,
urine output & blood loss,
extubation time & any complaints & adverse events such as pain, nausea, vomiting, shivering, delirium. |
| Comparator Agent |
Propofol |
Standardized anaesthesia protocol will be followed. In propofol group 20ml of 10mg per ml propofol will be taken. Preoxygenation will be done for 3 minutes with 100% oxygen. Injection glycopyrrolate, midazolam & fentanyl will be given followed by induction of anaesthesia by propofol over 10 seconds. Loss of response to verbal commands will be assessed. The dose of drug required & time taken for induction of anaesthesia will be noted. Pain on injection & myoclonus if present will be noted. Bag mask ventilation will be assessed & vecuronium will be given for neuromuscular blockade. Bag mask ventilation will continue with oxygen in sevoflurane for 3 minutes. Injection xylocard will be given 90 seconds prior to tracheal intubation. Direct laryngoscopy using Macintosh laryngoscope will be done & endotracheal intubation will be done with appropriate size PVC tube & bilateral air entry will be verified. Mechanical ventilation with appropriate settings will be done to maintain eucapnia. Vital monitoring(HR,SBP,DBP,MAP,EtCO2,SPO2,MAC) will be done continuously & recorded at baseline, 1min & 2min after induction, 3,5,10 min after intubation. Maintenance of anaesthesia will be done with sevoflurane in N2O & O2 targeting a MAC 0.8-1.2. Mannitol over 30 min, fentanyl & vecuronium infusion will be administered. Surgery will commence & after opening of dura brain relaxation score will be noted. Rest of the anaesthesia and extubation process will be managed as per standard protocol. Following parameters will be noted- duration of surgery, duration of anaesthesia, total requirement of drug, fluids & blood transfused, urine output & blood loss, extubation time & any complaints & adverse events such as pain, nausea, vomiting, shivering,delirium. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Forty four patients of either sex in the age group 18-60 years belonging to ASA 1&2 scheduled to undergo elective supratentorial craniotomies with full GCS, size of lesion less than 5cm & midline shift less than 5mm under general anaesthesia will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
The patients with refusal for study, hypertension, obesity, psychiatric disorder, pregnancy, lactation, other methods of brain relaxation being used or planned such as EVD will be excluded from the study. |
|
|
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 |
| Changes in mean arterial pressure in both groups |
1.At Baseline
2. 2 mins after induction
3. 3 mins after intubation
4. 5 mins after intubation
5. 10 mins after intubation
6. 3 mins after skull pin insertion
7. 5 mins after skull pin insertion
8. at the time of skin incision
9. At the time of bone flap removal
10. At the time of dural opening
11. At the time of skin suturing
12. 5 mins after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in heart rate
2. Brain relaxation score
3. Pain on injection
4. Myoclonic movements
5. Any adverse events or complications
in both the groups |
1.At Baseline
2 mins after induction
3 mins after intubation
5 mins after intubation
10 mins after intubation
3 mins after skull pin insertion
5 mins after skull pin insertion
at the time of skin incision
At the time of bone flap removal
At the time of dural opening
At the time of skin suturing
5 mins after extubation
2. After dural opening
3.On administering the induction drug
4. On administering the induction drug
5. After extubation |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/01/2024 |
| 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="0"
Months="8"
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 present prospective, randomized, double blind, interventional study will be done in the department of Anaesthesiology and Critical care in collaboration with department of Neurosurgery after obtaining approval PG Board of Studies and Institutional Ethical Committee. Witnessed written informed consent will be taken from patients then comparison of ketofol and propofol as anaesthetic induction agents in patients undergoing supratentorial surgery will be done. |