| CTRI Number |
CTRI/2025/07/091918 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two ways to monitor anasthesia to see which helps patients wake up faster from anasthesia in patients undergoing elective breast surgeries in a tertiary cancer care hospital |
|
Scientific Title of Study
|
A prospective randomized comparative study of recovery time by using bispectral index versus end tidal agent concentrate monitoring in patients undergoing elective breast surgeries in a tertiary cancer care hospital |
| 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 BABY LALMALSAWMI |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
| Address |
ROOM 101, FIRST FLOOR, SHANTHIDHAMA BLOCK,KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, BANGALORE, 560029
ROOM 105, Ground Floor, OT complex,KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, BANGALORE, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9612615935 |
| Fax |
|
| Email |
babylalmalsawmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HENJARAPPA K S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
| Address |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, OT COMPLEX, FIRSTV FLOOR,ROOM 105, DR MH MARIGOWDA ROAD BANGALORE 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9448933654 |
| Fax |
|
| Email |
drhenjarappa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BABY LALMALSAWMI |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, BANGALORE |
| Address |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, ROOM 101, FIRST FLOOR, SHANTHIDHAMA BLOCK, BANGALORE, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9612615935 |
| Fax |
|
| Email |
babylalmalsawmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, BANGALORE |
|
|
Primary Sponsor
|
| Name |
DR BABY LALMALSAWMI |
| Address |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, ROOM 101, FIRST FLOOR SHANTHIDHAMA BLOCK,BANGALORE |
| 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 BABY LALMALSAWMI |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY, BANGALORE |
DEPARTMENT OF ANAESTHESIOLOGY AND PAIN RELIEF
FIRST FLOOR, OT COMPLEX
Bangalore
KARNATAKA |
9612615935
babylalmalsawmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANAESTHETIC AGENT DESFLURANE |
NIL |
| Comparator Agent |
BISPECTRAL INDEX VERSUS END TIDAL ANAESTHETIC AGENT |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective breast surgery
2. Patients aged more than 18 years
3. American Society of Anaesthesiology (ASA) physical status 1 and 2
4. Provised consent to procedure |
|
| ExclusionCriteria |
| Details |
1. Patients with history of long term used of anti-convulsants, opiates, benzodiazepines, cocaine, alcohol
2. Patients with pre-existing renal, hepatic, cardiac disease and dementia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess extubation time and recovery time using bispectral index and end tidal anaesthetic agent |
2-3hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total consumption of desflurane, hemodynamic stability of the patients and discharge from post-anaesthetic care unit |
1-2hours |
|
|
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)
|
16/09/2025 |
| 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="2"
Months="0"
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 a randomized comparative study on recovery time from post operative procedure using two monitoring device bispectral index and end tidal anaesthetic agent. this two device have been proven to be effective for this purpose it also assess the anaesthetic depth of the patients as well. Group A will be the bispectral group where the value will be kept between 40-60 and Group B will be the end tidal anaesthetic agent group where the minimum alveolar concentratiuon (MAC) will be kept at 1. After shifting the patients to operation room, the will be connect to standard american socitey of anaesthsiology monitor like like heart rate, oxygen saturation , bloopd pressure,electrocardiogramand will recorded at baseline, at 5minustes, at 30 minustes, at 60 minutrs, at 120 minutes. For anaesthetic agent desflurane will be used and will be titrated according to the bispectral index value and end tidal agent value (MAC) and will be switch off an the last stitch of skin incision.the time taken for the patient to be extubated and recover from sugery will be recorded in both the group . |