| CTRI Number |
CTRI/2025/02/080013 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| 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
|
To know intraoperative brain relaxation and postoperative recovery using TIVA with propofol vs Desflurane anaesthesia following craniotomy in supratentorial tumours |
|
Scientific Title of Study
|
Effect of total intravenous anaesthesia using propofol versus desflurane anaesthesia on intraoperative brain relaxation and postoperative recovery following craniotomy for supratentorial tumours-a randomised controlled trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima |
| Designation |
Postgraduate student |
| Affiliation |
Bangalore medical college and research institute bangalore 560002 |
| Address |
Dept of anaesthesiology Bangalore medical college and research institute Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9481903068 |
| Fax |
|
| Email |
drmahima20021999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandhya K |
| Designation |
Professor |
| Affiliation |
Bangalore medical college and research institute Bangalore 560002 |
| Address |
Department of anaesthesiology
Bangalore medical college and research institute Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9972212417 |
| Fax |
|
| Email |
sandyaraghu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima |
| Designation |
Postgraduate student |
| Affiliation |
Banagalore medical college and research institute Bangalore 560002 |
| Address |
Department of anaetshesiology
Bangalore medical college and research institute Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
07259231961 |
| Fax |
|
| Email |
drmahima20021999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Mahima |
| Address |
Department of anaetshesiology
Bangalore medical college and research institute Bangalore 560002 |
| Type of Sponsor |
Other [self] |
|
|
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 Mahima |
Superspeciality hospital |
Department of anesthesiology Bangalore medical college and research institute Bangalore 560002
Bangalore
KARNATAKA |
7259231961
drmahima20021999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute Bangalore 560002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desflurane |
Intraoperative brain relaxation with Desflurane and postoperative recovery
Dose and frequency -adjusted according to the BIS SCORE route -inhalational
Total duration -surgery not exceeding more than 4 hrs |
| Comparator Agent |
TIVA with propofol |
intraoperative brain relaxation with TIVA with propofol and postoperative recovery
dose -100-150mcg/kg/min
Route -i/v
Frequency -adjusted according to the BIS scoring
Total duration -surgery not exceeding more than 4 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to give informed written consent
2.Patients of age group 18-60 yrs undergoing craniotomy for supratentorial tumor under general anesthesia
3.Patients belonging to ASA 1-3
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed written consent
2. Patients undergoing emergency craniotomies under general anesthesia
3. Mentally retarded patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scale on intraoperative brain relaxation |
Baseline to 135min after induction of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SOMCT
Postoperative return of cognitive function
|
Baseline to 135min after induction of anesthesia |
|
|
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 4 |
|
Date of First Enrollment (India)
|
09/02/2025 |
| 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
|
This is a randomized controlled study, we will enroll patient aged between 18-60yrs with ASA1-3, who are scheduled elective craniotomy for supratentorial tumors .Patients are randomly assigned in a 1:1 ratio to receive desflurane or TIVA anesthesia primary outcome is the satisfactory brain relaxation and secondary outcome is recovery of the patient following supratentorial craniotomies |