| CTRI Number |
CTRI/2025/03/083614 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of recovery in patients by different inhalational anesthetic agents with sedative undergoing surgery for brain tumors |
|
Scientific Title of Study
|
COMPARISION OF RECOVERY PROFILE OF SEVOFLURANE AND DESFLURANE WITH DEXMEDETOMIDINE IN PATIENTS UNDERGOING SURGERY FOR SUPRATENTORIAL TUMORS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMuthyala Pavankumar |
| Designation |
Postgraduate |
| Affiliation |
kasturba medical college ,mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8939548884 |
| Fax |
|
| Email |
dr.muthyalapavankumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sunil BV |
| Designation |
Additional Professor |
| Affiliation |
kasturba medical college, Mangaluru |
| Address |
Department of Anaesthesiology kasturba medical college
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sunil BV |
| Designation |
Additional Professor |
| Affiliation |
kasturba medical college, Mangaluru |
| Address |
Department of Anaesthesiology kasturba medical college
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Muthyalapavankumar |
| Address |
Department of Anaesthesiology ,
kasturba medical college ,mangalore |
| 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 |
| DrMuthyala Pavankumar |
kasturba medical college hospitals |
Department OF Anaesthesiology ,Kasturba medical college,mangaluru,575001
Dakshina Kannada
KARNATAKA |
8939548884
dr.muthyalapavankumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe ,kasturba medical college,mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.patients having GCS of 15 preoperatively
2.patinets undergoing elective craniotomy for supratentorial lesions
|
|
| ExclusionCriteria |
| Details |
1.patients with intracarnial hypertension
2.patients with gross cerebral edema on CT IMAGING
3.pregnancy
4.patients who planned for postoperative mechanical ventilation
5.patients with intellectual disability |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the time taken for emergence, Extubation and orientation after sevoflurane and desflurane with dexmedetomidine
2.to assess recovery of cognitive function after sevoflurane and desflurane with dexmedetomidine
|
post-operation Immediately (13-15 min) after for both the anesthetic agents |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess intraoperative brain condition,and haemodynamics |
intraop haemodynamics ;
Baseline
Pre induction
immediate post induction
after 5 min
after 10 min
after 15min
after 20min
after 30 min
after 60min
after 90min
after 120min
pre induction |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="10" |
|
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
|
comparision of recovery profile of sevoflurane and desflurane with dexmedetomidine in patients undergoing surgery for supratentorial tumors To compare time taken for emergence , extubation and orientation To assess recovery of cognitive function after sevoflurane and desflurane with dexmedetomidine |