| CTRI Number |
CTRI/2026/04/109292 [Registered on: 24/04/2026] Trial Registered Prospectively |
| Last Modified On: |
23/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare two inhalational agents to determine which is better |
|
Scientific Title of Study
|
RANDOMISED STUDY TO EVALUATE RECOVERY PROFILE OF SEVOFLURANE VS ISOFLURANE IN CARDIAC PATIENTS COMING FOR NON-CARDIAC SURGERIES UNDER GENERAL ANAESTHESIA
“A PROSPECTIVE COMPARATIVE
RANDOMISED STUDY TO EVALUATE RECOVERY PROFILE OF SEVOFLURANE VS ISOFLURANE IN CARDIAC PATIENTS COMING FOR NON-CARDIAC SURGERIES UNDER 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 |
dr manthrigalla bhavya |
| Designation |
post graduate |
| Affiliation |
D Y Patil school of medicine |
| Address |
Department of Anaesthesia,2nd floor A Block,D Y Patil Hospital,Ayyappa Temple Road,D y patil vidyanagar,sector 5,Nerul,Navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8919262559 |
| Fax |
|
| Email |
manthribhavya4688@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil school of medicine |
| Address |
Department of Anaesthesia,2nd floor A Block,D Y Patil Hospital ,Ayyappa temple road,D Y Patil vidyanagar,sector 5,nerul,navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
98669984017 |
| Fax |
|
| Email |
dr.manjula.sarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil school of medicine |
| Address |
Department of Anaesthesia,2nd floor A Block,D Y Patil hospital ,Ayyappa Temple road,D Y Patil vidyanagar,sector 5,Nerul,Navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
98669984017 |
| Fax |
|
| Email |
dr.manjula.sarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| D y Patil school of medicine,Department of Anaesthesia ,2nd floor A block,Ayyappa temple road,D Y Patil vidyanagar,sector 5,Nerul Navi mumbai Thane MAHARASHTRA 400706 India
|
|
|
Primary Sponsor
|
| Name |
D Y Patil Hospital |
| Address |
Second Floor, A Block Department of Anaesthesia D Y Patil hospital Ayappa Temple Rd, Dr D Y Patil Vidyanagar Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 manthrigalla bhavya |
D Y Patil hospital |
Department of anaesthesia,2nd floor A Block, ayyappa temple road D Y Patil vidyanagar,sector 5 Nerul Navi Mumbai , 400706
Thane
MAHARASHTRA |
8919262559
manthribhavya4688@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Biomedical and health Research ,D. Y Patil deemed to be university school of medicine , navi mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ISOFLURANE INHALATIONAL AGENT |
Isoflurane is used for maintenance of cardiac patients posted for non cardiac surgery. Hemodynamics will be recorded at time intervals-Time from stoppage of inhalational agent, before extubation, after extubation, shifting to recovery, before shifting to ward. Consciousness level will also be recorded after stoppage of Isoflurane. |
| Intervention |
SEVOFLURANE INHALATIONAL AGENT |
Sevoflurane is used for maintenance of cardiac patients posted for non cardiac surgery. Hemodynamics will be recorded at time intervals- time from stoppage of inhalational agent, before extubation, after extubation, shifting to recovery, before shifting to ward. Consciousness level will also be recorded after stoppage of sevoflurane. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Cardiac patients coming for non-cardiac surgeries
Anticipated duration of surgery between 1-3 hours |
|
| ExclusionCriteria |
| Details |
Pregnant Patients.
Patient with Renal and Hepatic diseases
Patient not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time of emergence of inhalational agent and extubation criteria following sevoflurane and isoflurane anesthesia in cardiac patients coming for non-cardiac surgeries, post operation. |
Baseline (immediately before discontinuation of inhalational agent),At discontinuation of inhalational agent (0min),At extubation,5 minutes post extubation .At the time of shifting to recovery,At the time of shifting to ward |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess hemodynamic parameters |
Baseline (immediately before discontinuation of inhalational agent),At discontinuation of inhalational agent (0 min) ,At extubation ,5 minutes post extubation ,At the time of shifting to recovery,At the time of shifting to ward |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/05/2026 |
| 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 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
|
Cardiac patients posted for non cardiac surgery will be induced with
general anaesthesia, After completion of surgery, Inhalational agent will be
stopped and vitals will be noted and when patient will fulfil the recovery
criteria extubation will be done. The time of
emergence of inhalational agent will
be compared and recovery profile
following sevoflurane and isoflurane anesthesia in cardiac patients coming for non-cardiac surgeries will be done post-operation. After shifting to
recovery vitals will be monitored. Before shifting the
patient from recovery to ward modified ALDRETE score will be monitored. |