| CTRI Number |
CTRI/2026/03/105118 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the quality of anesthesia administered by using Isoflurane (sedating agent) in patients undergoing surgery while being fully unconscious using GE Aisys CS 2 anesthesia machine by manually adjusting the anesthesia agent flow rate vs automated control by the anesthesia machine |
|
Scientific Title of Study
|
Automated vs. Manual Control of Isoflurane Delivery for Quality and Recovery in Adult Surgical Patients Under General Anesthesia: An open-label randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Afreed A |
| Designation |
Junior resident |
| Affiliation |
JIPMER - Puducherry |
| Address |
Dr Afreed, Junior Resident, Department of Anesthesiology and critical care, JIPMER, puducherry
JIPMER Campus, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605008
India |
| Phone |
8754973443 |
| Fax |
|
| Email |
kokanafreed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sekar L |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER - Puducherry |
| Address |
Dr. Sekar L, Asssitant Professor, Department of Anesthesiology and Critical Case, JIPMER, Puducherry
JIPMER Campus, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605008
India |
| Phone |
8146555023 |
| Fax |
|
| Email |
drsekarvmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Afreed A |
| Designation |
Junior resident |
| Affiliation |
JIPMER - Puducherry |
| Address |
Afreed A, Junior Resident, Department of Anesthesiology and critical care, JIPMER, Puducherry
JIPMER Campus, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605008
India |
| Phone |
8754973443 |
| Fax |
|
| Email |
kokanafreed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Danvanthri Nagar, Puducherry, Pondicherry, India - 605008 |
|
|
Primary Sponsor
|
| Name |
JIPMER Puducherry |
| Address |
JIPMER, JIPMER Campus, Dhanvantri Nagar, Puducherry, Pondicherry, India - 605008 |
| 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 Afreed A |
Jawaharalal Institute of Postgraduate Medical Education and Research |
Operation theatre complexes, JIPMER, Dhanvanthri Nagar, Puducherry, Pondicherry, India
Pondicherry
PONDICHERRY |
8754973443
kokanafreed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Et control group |
Usage of automated Et control mode of isoflurane delivery during general anesthesia with GE Aisys CS2 workstation |
| Comparator Agent |
Manual control group |
Usage of Manual mode of isofluranedelivery for general anesthesia with GE Aisys CS2 anesthesis workstation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- ASA 1 to 3 patients
- Patients undergoing surgery with general anesthesia
- Intubated with PVC Endo tracheal tube |
|
| ExclusionCriteria |
| Details |
- Patient undergoing additional regional anesthesia technique
- Patients not willing to participate in the study
- Patients whose expected surgery duration is less than 3 hours
- Pregnant/ Lactating mothers
- Patient with psychiatric/ neurological disease/ taking any CNS drugs
- Patients with any pre existing psychiatric conditions on medication. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for recovery from amesthesia - vocal response and tongue protrusion |
baseline value - only one value taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare time between stopping of isoflurane and tracheal extubation |
To compare time between stopping of isoflurane and tracheal extubation |
| to estimate percent time BIS deviation from target +/- 10% between two study groups |
through out surgery duration BIS monitoring |
| To estimate percent time Heart rate and mean arterial pressure deviation between two study groups |
Throughout surgery HR and MAP monitoring at every 5 mins interval |
| To compare the total amount of isoflurane used throughout the surgery in two study groups. |
Value obtained from GE Aisys CS2 at the end of each surgery. |
| To comapre the total amount of fresh gases, oxygen, nitrous oxide used in the surgery in two study groups |
Values obtained from GE Aisys CS2 anesthesia machine at the end of each surgery |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/03/2026 |
| 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="6"
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
|
This study aims at establishing the benefits of Et control mode of anesthesia agent delivery by GE Aisys CS2 anesthesia machine. We compare intra operative hemodynamics of the patient and recovery from anesthesia as a tool to compare manual mode and Et control mode with respect to the cost incurred in both these modes respectively. |