| CTRI Number |
CTRI/2025/10/096148 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Monitoring of Depth of Anesthesia while comparing measured values with clinical assessment during a titrated Etomidate Induction. |
|
Scientific Title of Study
|
Monitoring Depth Of Anesthesia colon Bi Spectral Index versus Observer’s Assessment of Anxiety And Sedation Scale during Titrated Etomidate Induction. |
| 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 Anurag Yadava |
| Designation |
Head of Department comma Professor |
| Affiliation |
Bhopal Memorial Hospital and Research Centre |
| Address |
Department of Anesthesiology Bhopal Memorial Hospital and Research Centre comma Bhopal
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
939981334 |
| Fax |
|
| Email |
anuragyadava@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Yadava |
| Designation |
Head of Department comma Professor |
| Affiliation |
Bhopal Memorial Hospital and Research Centre |
| Address |
Department of Anesthesiology Bhopal Memorial Hospital and Research Centre comma Bhopal
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
939981334 |
| Fax |
|
| Email |
anuragyadava@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurpreet |
| Designation |
Post Graduation Student |
| Affiliation |
Bhopal Memorial Hospital and Research Centre |
| Address |
Doctor Hostel 1 comma Room 3 comma Bhopal Memorial Hospital and Research Centre
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
7087895263 |
| Fax |
|
| Email |
gurpreetsingh42355@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTRE ICMR BHANPUR BHOPAL 462038 MADHYA PRADESH INDIA |
|
|
Primary Sponsor
|
| Name |
BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTRE ICMR |
| Address |
Bhopal Memorial Hospital and Research Centre comma Bhanpur comma Bhopal comma 462038 comma Madhya Pradhesh comma 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 Gurpreet |
Bhopal Memorial Hospital and Research Centre |
ROOM 3 DOCTOR HOSTEL 1 BMHRC CAMPUS Bhopal Memorial Hospital and Research Centre comma Bhanpur comma Bhopal comma 463028 comma Madhya Pradesh comma India
Bhopal
MADHYA PRADESH |
7087895263
-
gurpreetsingh42355@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHOPAL MEMORIAL HOSPITAL AND RESEARCH CENTRE COMMA 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I or II
BMI 18 to 30 kg per metre square |
|
| ExclusionCriteria |
| Details |
Severe Heart lung kidney function disease
Compromised Adrenal Function.
Expected difficult intubation
Hypoalbuminemia less than 2.5 mg per dl
rule out Aspiration risks
• Neurological - schizophrenia, epilepsy, hearing, intellectual disability.
• Psychiatric Disorder patients on anti psychotic drug treatment.
Long term Sedation psychoactive drug intake
Allergy
Sepsis or Septic shock
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess the corelation between BIS value and OAAS at 5 comma 4 comma 3 comma 2 comma 1 for titrated Etomidate induction
Corelation between patients preOp Anxiety score and total amount of drug used to achieve OAAS of 1 |
ASSESSMENT OF THE OAAS WITH AMOUNT OF DRUG USED WITH VITALS IS DONE AT 1 MINUTE 2 3 4 5 MINUTES UNTIL A SCORE OF OAAS 1 IS ACHIEVED WHICH IS NO RESPOSNSE
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
07/11/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - To be accessed from BHMRC BHOPAL
- For how long will this data be available start date provided 25-12-2027 and end date provided 31-10-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This trial is conducted in order to evaluate the co relation between BIS Index and Observer Assessment of Alertness and sedation scale while giving a titrated dose of etomidate In the parent study this evaluation was done using propofol and it was observed that patient has a score of one in OAAS scale wirh a BIS index of varying between 70 to 80 and thus intubation was performed after giving adjuvants like fentanyl and then relaxant My study is to evaluate the same using etomidate while also assessing the amount of drug that will used depending upon the preoperative anxiety score of the patient This study will be conducted in 106 patients.
|