| CTRI Number |
CTRI/2024/10/074875 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two inhalational agents and assess cognitive brain function in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparative study of clinical effect of sevoflurane vs desflurane on cognitive brain function in patients undergoing surgery with general 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 |
G R Sukanya |
| Designation |
Junior Resident -2 |
| Affiliation |
Grant Medical College and JJ Hospital |
| Address |
300 Resident Room 313
3rd floor
junior resident -2
Department of anaesthesia Grant Medical College and JJ Hospital ,
byculla
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9884840875 |
| Fax |
|
| Email |
sukanyagr10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Ganeriwal |
| Designation |
Associate Professor |
| Affiliation |
Grant Medical College and JJ Hospital |
| Address |
Department of Anaesthesia Grant Medical College and JJ Hospital. Byculla Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9821300699 |
| Fax |
|
| Email |
veenaganeriwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Ganeriwal |
| Designation |
Associate Professor |
| Affiliation |
Grant Medical College and JJ Hospital |
| Address |
Department of Anaesthesia Grant Medical College and JJ Hospital. Byculla Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9821300699 |
| Fax |
|
| Email |
veenaganeriwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
Grant government medical college
Byculla
Mumbai 400008 |
|
|
Primary Sponsor
|
| Name |
G R Sukanya |
| Address |
Department of Anaesthesiology
Grant Government Medical College
Byculla Mumbai -08 |
| 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 G R SUKANYA |
Grant Government Medical College & Sir JJ group of Hospitals Institutional ethics committe |
Department of Anaesthesiology
6th Floor Main Building
Grant Government Medical college & Sir JJ Group of Hospitals
Byculla Mumbai
400008
Mumbai
MAHARASHTRA |
9884840875
sukanyagr10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Grant Government Medical college ,Mumbai -8 IEC/PG/108/apr/2024 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: R419||Unspecified symptoms and signs involving cognitive functions and awareness, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
desflurane inhyalational agent |
inhalational desflurane 2-6% in combination with nitrous oxide 50% is which corresponds to a MAC of 1-1.8MAC is maintained till the end of surgery |
| Intervention |
sevoflurane Inhalational agent |
Inhalational sevoflurane 1-1.5% in combination with nitrous oxide 50% which coressponds to 1-1.8MAC will be maintained till the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients willing to participate in the study. 2) Patients with ASA grade 1and 2 with normal cognitive function. 3)Patients undergoing surgery with General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Patients not willing for the study. 2) Patients with abnormal hepatic,neurological,pulmonary,psychiatry,cardiovascular function. 3) Patients who had already participated in another clinical trial. 4) Emergency cases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in cognitive function outcome after using sevoflurane or desflurane in general anaesthesia |
assessment of cognitive function immediate postop and 24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the incidence & risk factors of delirium & to evaluate the hemodynamic changes in the intraoperative period |
delirium after extubation immediately ,after 6 hours & 24 hours respectively.
hemodynamic status during the procedure |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/10/2024 |
| Date of Study Completion (India) |
17/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
the study is a randomised control study done to compare the outcome of sevoflurane and desflurane on cognitive brain function in the postoperative period. To evaluate the incidence and risk factors of delirium and to evaluate hemodynamical changes during intraoperative period. The study group will comprise a two group of 49 each. Preoperative assessment of MMSE score will be done of the patient. The MMSE score assessment will be done in the immediate postoperative period and after 24 hours of the postoperative period.THe data willl be collected and analysed. |