| CTRI Number |
CTRI/2025/11/097553 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Randomised Comparative Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of isoflurane and sevoflurane via Bispectral index monitoring |
|
Scientific Title of Study
|
The role of Bispectral Index Monitoring in optimising intraoperative volatile anaesthetic delivery, a comparative assessment of Isoflurane and Sevoflurane |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Oshon Patni |
| Designation |
Resident Doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institue and Research Centre |
| Address |
Anaesthesia Department,General OT complex, 2nd floor,Dhiraj Hospital,Smt.Bhikiben Kanjibhai Shah Medical Institue and Research Centre,Waghodiya,Piparia,Vadodara,Gujarat,391760
Vadodara
GUJARAT
391760
India |
| Phone |
9479274001 |
| Fax |
|
| Email |
oshinpatni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh K Chauhan |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institue and Research Centre |
| Address |
Anaesthesia Department,General OT Complex,2nd Floor Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institue and Research Centre, Waghodiya, Piparia, Vadodara Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh K Chauhan |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institue and Research Centre |
| Address |
Anaesthesia Department, General OT Complex,2nd Floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institue and Research Centr, Waghodia,Pipariya,Vadodara, Gujarat, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt. Bhikiben Kanjibhai Shah Medical Institue and Research Centre,Waghodia,Pipariya,Vdodara, Gujarat, 391760 |
|
|
Primary Sponsor
|
| Name |
OSHIN PATNI |
| Address |
STAFF QUARTER D BLOCK SUMANDEEP VIDYAPEETH WAGHODIA ROAD VADODARA GUJARAT 391760 |
| 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 Dinesh K Chauhan |
Smt. Bhikiben Knjibhai Shah Medical Institue and Reserch Centre |
Anaesthesia Department,2nd Floor, General OT Complex,Smt. Bhikiben Kanjibhai Shah Medical Institue and Research Centre,Sumandeep Vidyapeeth,Waghodiya,Pipapriya,Vadodara, Gujarat,391760
Vadodara
GUJARAT |
9099014672
drdinesh77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z13||Encounter for screening for otherdiseases and disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Isoflurane, Routinely used inhalational anaesthetic agent |
Patient receiving Isoflurane for maintenence of General Anaesthesia as per standard anaesthesia practice.BIS monitoring will be used to monitor depth of anaesthesia.
Dose: Variable end tidal concentration adjusted as clinically required
Duration: Throughout intraopertaive period
Arm type: Cohort 1 (Exposure group I) |
| Comparator Agent |
Sevoflurane, Routinely used inhalational Anaesthetic agent |
Patient receiving Sevoflurane for maintenence of General Anaesthesia as per standard anaesthesia practice.BIS monitoring will be used to monitor depth of anaesthesia. Dose: Variable end tidal concentration adjusted as clinically required Duration: Throughout intraopertaive period Arm type: Cohort 2(Exposure group S) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged between 18 to 65 years
2.American Society of Anaesthesiologists (ASA) Physical Status I or II:
3.Patients scheduled for elective surgeries under general anaesthesia using volatile agents (Isoflurane or Sevoflurane)
4.Expected duration of surgery between 1 to 3 hours
5.Patients able and willing to provide written informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This Prospective Randomised Comparative Study will help to compare efficacy between Isoflurane and Sevoflurane in perioperative outcome in patients undergoing general anaesthesia via Bispectral Index Monitoring |
DURING INDUCTION
During Induction
During Maintenence
After Extubation
1 min
2 min
5 min
10 min
15 min
30 min
45 min
60 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/12/2025 |
| 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="6"
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
|
This prospective, randomized, comparative study evaluates the role of Bispectral Index (BIS) monitoring in optimizing intraoperative volatile anaesthetic delivery using Isoflurane and Sevoflurane in 70 ASA I–II patients undergoing elective surgeries under general anaesthesia. Patients are divided into two groups receiving either Isoflurane or Sevoflurane, maintaining BIS between 40–60. Intraoperative hemodynamics, BIS values, and recovery parameters such as eye opening, motor response, and extubation times are assessed, along with postoperative nausea, vomiting, and awareness. The study aims to determine whether BIS-guided anaesthesia improves recovery, reduces anaesthetic consumption, enhances hemodynamic stability, and minimizes intraoperative awareness and postoperative complications. |