| CTRI Number |
CTRI/2025/12/098577 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To determine the volume of anaesthetic agent required to maintain depth of anaesthesia using patient state index and bispectral index |
|
Scientific Title of Study
|
Comparison of patient state index and bispectral index for sevoflurane consumption and end tidal sevoflurane consumption in patients undergoing laparoscopic surgical and gynaecological procedures |
| 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 Rangalakshmi S |
| Designation |
Professor, Dept of Anaesthesia |
| Affiliation |
|
| Address |
RajaRajeswari Medical College and Hospital 202 Kambipura Mysore Road Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9901703030 |
| Fax |
|
| Email |
rangbharat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rangalakshmi S |
| Designation |
Professor, Dept of Anaesthesia |
| Affiliation |
|
| Address |
RajaRajeswari Medical College and Hospital 202 Kambipura Mysore Road Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9901703030 |
| Fax |
|
| Email |
rangbharat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rangalakshmi S |
| Designation |
Professor, Dept of Anaesthesia |
| Affiliation |
|
| Address |
RajaRajeswari Medical College and Hospital 202 Kambipura Mysore Road Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9901703030 |
| Fax |
|
| Email |
rangbharat@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL, KAMBIPURA, BANGALORE, KARNATAKA, INDIA |
|
|
Primary Sponsor
|
| Name |
RajaRajeswari Medical College & Hospital |
| Address |
RajaRajeswari Medical College and Hospital, 202,Kambipura,Mysore Road, Bangalore 560 074 Karnataka, India |
| 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 RANGALAKSHMI S |
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL BANGALORE INDIA |
202 Kambipura Mysore Road Bangalore 560 074 Karnataka India
Bangalore
KARNATAKA |
9901703030
rangbharat@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 |
| Healthy Human Volunteers |
Patients undergoing laparsocopic surgical and gynaecological prcedures classified as ASA 1-2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bispectral Index |
The Bispectral Index (BIS) is a quantitative measure derived from a patients electroencephalogram (EEG) that assesses the depth of anesthesia |
| Intervention |
Patient state index |
The Patient State Index (PSI) is a numerical measure of the depth of a patients sedation or anesthesia. It is calculated by a 4-channel electroencephalograph (EEG) monitor using a proprietary algorithm that analyzes brainwave activity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1-2
Scheduled for Laparoscopic gynaecological/surgical procedures |
|
| ExclusionCriteria |
| Details |
Known neurological disorders
combined regional- general anaesthesia
pregnant or lactating women
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the volume of sevoflurane consumed (in ml) in patients, while monitoring depth of anaesthesia using Bispectral Index versus Patient State Index
|
Baseline- Time of intubation,5mins,10mins,15mins,20mins,25mins,30mins,35 mins,40mins,45 mins,50mins,55mins,60mins
Post one hour of intubation -every 15mins till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To assess the end-tidal sevoflurane concentration (ETSevo) during surgery in both groups
-To compare recovery profiles including time to extubation & response to verbal commands between the two groups.
-To identify any differences in the incidence of intraoperative awareness with questionnaire or anaesthesia-related adverse events. |
Baseline- Time of intubation,5mins,10mins,15mins,20mins,25mins,30mins,35 mins,40mins,45 mins,50mins,55mins,60mins
Post one hour of intubation -every 15mins till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
31/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
Accurate monitoring of anaesthetic depth is essential for optimizing drug delivery, ensuring patient safety, preventing awareness during anaesthesia and enhancing recovery outcomes and reducing cost during surgical procedures. In laparoscopic surgical and gynaecological procedures , where optimal anaesthetic dose and rapid emergence are desirable, the use of brain-function monitors can guide more precise titration of volatile anaesthetic agents such as sevoflurane.This achieves more significance in ASA 3 and 4 patients where optimal anesthetic dose will reduce adverse effects. Two widely used parameters - the Bispectral Index (BIS) and the Patient State Index (PSI)- offer real-time assessment of a patient’s level of consciousness based on processed EEG data. While both aim to prevent intraoperative awareness and reduce anaesthetic consumption, they rely on different proprietary algorithms and EEG interpretations. BIS analyzes EEG bispectral and power spectral data, while PSI incorporates bilateral EEG coherence and anterior-posterior phase relationships. |