| CTRI Number |
CTRI/2021/07/035116 [Registered on: 26/07/2021] Trial Registered Prospectively |
| Last Modified On: |
16/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to prevent intraoperative awareness and recall under anaesthesia using Bispectral index monitoring and reduce dosage of anaesthetic drugs |
|
Scientific Title of Study
|
BIS (Bispectral Index) The current tool for monitoring unintended awareness and depth of anaesthesia |
| Trial Acronym |
Depth of anaesthesia |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHeena Chhanwal |
| Designation |
Professor and HOD, Dept. of anaesthesia |
| Affiliation |
GCS medical college, hospital and research center |
| Address |
Department Of Anaesthesia,
GCS Medical college, Hospital and Research Centre, Naroda road, Ahmedabad
Department Of Anaesthesia,
GCS Medical college, Hospital and Research Centre, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9925497393 |
| Fax |
07922201915 |
| Email |
drmrshc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHeena Chhanwal |
| Designation |
Professor and HOD, Dept. of anaesthesia |
| Affiliation |
GCS medical college, hospital and research center |
| Address |
Department Of Anaesthesia,
GCS Medical college, Hospital and Research Centre, Naroda road, Ahmedabad
Department Of Anaesthesia,
GCS Medical college, Hospital and Research Centre, Naroda road, Ahmedabad
GUJARAT
380025
India |
| Phone |
9925497393 |
| Fax |
07922201915 |
| Email |
drmrshc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHeena Chhanwal |
| Designation |
Professor and HOD, Dept. of anaesthesia |
| Affiliation |
GCS medical college, hospital and research center |
| Address |
Department Of Anaesthesia,
GCS Medical college, Hospital and Research Centre, Naroda road, Ahmedabad
Department Of Anaesthesia,
GCS Medical college, Hospital and Research Centre, Naroda road, Ahmedabad
GUJARAT
380025
India |
| Phone |
9925497393 |
| Fax |
07922201915 |
| Email |
drmrshc@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College, Hospital & Research Centre |
|
|
Primary Sponsor
|
| Name |
GCS Medical College Hospital Research CentreAhmedabad |
| Address |
Department Of Anaesthesia,
GCS medical College, Hospital & Research Centre, Naroda Road,Ahmedabad, Gujarat ,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 HEENA CHHANWAL |
GCS MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE |
Department Of Anaesthesia, GCS Medical College, Hospital & Research Centre, Naroda Road, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
9925497393
07922201915
drmrshc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bispectral Index Monitoring System- Quadro Sensor to be used |
to study intraoperative awareness in patients of BIS group using QUADRO sensor
in BIS group and to calculate dosage of anaesthetic agent-propofol |
| Comparator Agent |
to compare the awareness by Quadro sensor of BIS Group to NON- BIS(BIS Not USEd) group comparison using modified questionarie |
to compare the awareness in BIS group and Non - BIs group patients (BIS not used ) and to compare the total dosage of propofol in both groups |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
100 patients Of American society of anaesthesiologists grade I/II, aged 20-60 years, weighing 40-75 kg, posted for elective operative procedures of duration 30 minute to 3 hours. |
|
| ExclusionCriteria |
| Details |
patients with ASA 3 & 4, consent refusal, psychiatric illness, language barrier, pregnancy or known allergy to propofol or its emulsion, patients on regular sedatives or narcotic medications, emergency surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| was to monitor the intra-operative awareness using BIS monitoring system |
immediately after extubation, 2 hours after shifting in post-operative recovery and before patient shifted to ward. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Propofol consumption (loading and maintenance) in both groups |
after completion of surgery |
| Hemodynamic parameters monitoring in both groups |
prior to induction , induction , intraoperatively, extubation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/07/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Awareness under general anaesthesia is an unpleasant the phenomenon that usually goes unnoticed and neglected. Intraoperative awareness may be due to inadequate depth of anaesthesia, cheaper and less effective drugs, lack of proper monitoring equipments for providing anesthesia, untrained medical staff. Our Aim is To assess the intraoperative awareness during general anaesthesia and titrate amount of anesthetic agents according to BIS values among patients and monitor hemodynamic parameters throughout the surgery
adult Patients of ASA 1,2 undergoing elective surgical procedures in various specialties under general anesthesia will be included after taking informed consent .they will be randomly divided in 2 groups of 50 each -group BIS and NON BIS. Post operatively ,post extubation and in post anaesthesia care unit, anesthesiologist (not involved in administering anesthesia) assessees intraoperative awareness using modified form of Brice questionnaire at various time intervals. Hemodynamic parameters will be monitored and total propofol consumption to be calculated.
|