| CTRI Number |
CTRI/2022/04/041940 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
20/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of effect of anesthestic agents on the outcome of the patients sedule for brain tumor surgery |
|
Scientific Title of Study
|
Comparative evaluation of sevoflurane and desflurane for intraoperative brain condition, hemodynamics and postoperative recovery in patients undergoing supratentorial craniotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiran B Patel |
| Designation |
Assistant professor |
| Affiliation |
B. J. Medical College, Ahmedabad |
| Address |
F3 first floor department of anesthesia civil hospital Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Engineer |
| Designation |
Professor |
| Affiliation |
B. J. Medical College, Ahmedabad |
| Address |
F3 first floor department of anesthesia civil hospital Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Engineer |
| Designation |
Professor |
| Affiliation |
B. J. Medical College, Ahmedabad |
| Address |
F3 first floor department of anesthesia civil hospital Asarwa Ahmedabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Civil hospital, Ahmedabad Health and Family welfare Department, Government of Gujarat |
|
|
Primary Sponsor
|
| Name |
Health and family welfare department |
| Address |
7th floor 7th block new secretariate Gandhinagar Gujarat |
| 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 Kiran B Patel |
Civil hospital |
F5 2nd floor civil hospital Asarwa Ahmedabad
Ahmadabad
GUJARAT |
9428804290
kiru4576@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General anaesthesia and endotracheal intubation |
General anaesthesia and endotracheal intubation done and inhalation agents Sevoflurane and desflurane to be given |
| Comparator Agent |
Inhalation anaesthetic agents desflurane amd Sevoflurane |
Comparision of desflurane and Sevoflurane for intraoperative brain condition haemodynamics and postoperative recovery in patients undergoing supratentorial craniotomy. It will be done from preoperatively recording baseline parameters to poetoperatively three hours after regaining consciousness . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I-III
Glassgow coma scale 15
Craniotomy for supratentorial expanding lesions |
|
| ExclusionCriteria |
| Details |
Refusal to sign consent
Pregnancy
Known allergy to any anaesthetic drugs
Glassgow coma scale <15 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time for Postoperative cognitive function recovery
Postoperative recovery outcome variables including emergence time, extubation time, the time required to reach Aldrete score 9 |
From stopping anesthesia agents and completion of surgery to postoperative six hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra-operative haemodynamics
Degree of brain swelling
Intraoperative and postoperative complications |
From preoperative baselines data recording to postoperative six hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/04/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Inhaled volatile anaesthetics remain the most widely accepted drugs for maintenance of general anaesthesia in neurosurgical operations due to their ease of administration, the availability of end-tidal agent monitoring, and predictable intra-operative and recovery characteristics. A new dimension had been added to recovery from anaesthetics especially after the introduction of less soluble inhalational anaesthetics, sevoflurane and desflurane.Sevoflurane with prolonged administration, recovery times may be delayed and this benefit would be lost.Desflurane is a volatile anaesthetic known to have early recovery from anaesthesia due to its low blood solubility and low blood-gas (0.42) and tissue-blood partition coefficients resulting in a more rapid wash in and wash out in comparison to the other known volatile anaesthetics.However, there was much debate on its use in neurosurgery because it possesses a vasodilator effect on cerebral blood vessels. However, no variation in intracranial pressure (ICP) in normocapnic patients undergoing removal of supratentorial tumors using desflurane anesthesia was demonstrated. |