| CTRI Number |
CTRI/2025/04/084227 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Balanced anaesthesia used in supratentorial craniotomy surgery |
|
Scientific Title of Study
|
An analysis of clinical effects on supratentorial craniotomy surgery without neuromuscular blocking agents during maintenance phase of anaesthesia. |
| 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. Mohamed Anus Thoufeeque S |
| Designation |
Post Graduate in M.D Anaesthesiology |
| Affiliation |
Institute of Anaesthesiology,Government Rajaji Hospital,Madurai Medical College,Madurai |
| Address |
No-249,Institute of Anaesthesiology,Government Rajaji Hospital&Madurai Medical College,Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
6380037643 |
| Fax |
|
| Email |
thoufeeqcmc266@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vairavarajan MD |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Institute of Anaesthesiology,Government Rajaji Hospital,Madurai Medical College,Madurai |
| Address |
No-249,Institute of Anaesthesiology,Government Rajaji Hospital & Madurai Medical college,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9842190336 |
| Fax |
|
| Email |
drvairav@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mohamed Anus Thoufeeque S |
| Designation |
Post Graduate in M.D Anaesthesiology |
| Affiliation |
Institute of Anaesthesiology,Government Rajaji Hospital,Madurai Medical College,Madurai |
| Address |
No-249,Institute of Anaesthesiology,Government Rajaji Hospital & Madurai Medical College,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
6380037643 |
| Fax |
|
| Email |
thoufeeqcmc266@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Anaesthesiology,Government Rajaji Hospital & Madurai Medical College,Madurai,Tamil Naidu
625020
India |
|
|
Primary Sponsor
|
| Name |
Dr Mohamed Anus Thoufeeque S |
| Address |
No-249,Institute of Anaesthesiology,Government Rajaji Hospital & Madurai Medical College,Madurai
Tamil Nadu
625020
India |
| 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 Mohamed Anus Thoufeeque S |
Institute of Anaesthesiology,Government Rajaji Hospital & Madurai Medical College,Madurai |
No.2&3,Neurosurgery OT,SSB Block,Government Rajaji Hospital & Madurai Medical College,Madurai
Madurai
TAMIL NADU |
06380037643
thoufeeqcmc266@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Madurai Medical College & Government Rajaji Hospital,Madurai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One group of patients after intubation, anaesthesia maintained by Nitrous oxide, Oxygen,Desflurane, Dexmedetomidine and propofol infusion. |
Another group of patients after intubation anaesthesia maintained with Nitrous oxide, Oxygen, Desflurane and Atracurium (Neuromuscular blocking agents). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists(ASA) physical status I & II,
Glasgow Coma Score of 15,
Undergoing elective craniotomy surgery for supratentorial lesions. |
|
| ExclusionCriteria |
| Details |
Refusal to consent,
Known hypersensitivity to drugs being used,
Pregnant and lactating patients,
Sick sinus syndrome,
Patients on beta blockers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To elicit the clinical effects and physiological parameters during the maintenance phase of anaesthesia in patients undergoing supratentorial craniotomy surgery |
Outcomes will assessed during intraoperatively till the end of surgery and postoperatively for 1 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE TIME TAKEN FOR DISCHARGE FROM POST ANAESTHETIC CARE UNIT |
POSTOPERATIVE PERIOD |
| To assess the time taken for discharge from the post anaesthetic care unit |
Postoperatively for 1 hour |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/04/2025 |
| 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="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
|
Neuromuscular blocking agents have been one of the cornerstones of anaesthesia. When balanced anaesthesia with desflurane,dexedetomidine,propofol infusion and scalp block will prelude the use of neuromuscular blocking agents in patients undergoing supratentorial craniotomy surgery under intense hemodynamic monitoring. |