| CTRI Number |
CTRI/2020/07/026476 [Registered on: 10/07/2020] Trial Registered Prospectively |
| Last Modified On: |
03/07/2020 |
| 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
|
IN SURGERIES PERFORMED UNDER GENERAL ANESTHESIA,WE WILL USE ANESTHETIC GAS AND DRUG ACCORDING TO DEPTH OF ANESTHESIA BY USING A SCALE WHICH IS CALLED BISPECTRAL INDEX MONITORING |
|
Scientific Title of Study
|
ROLE OF BISPECTRAL INDEX (BIS) MONITORING VS END TIDAL ANESTHETIC GAS CONCENTRATION IN PREDICTING RECOVERY TIME AND EXTUBATION IN SURGERIES PERFORMED UNDER GENERAL ANESTHESIA |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALOK KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, IGIMS PATNA
Patna
BIHAR
800014
India |
| Phone |
7992454344 |
| Fax |
|
| Email |
alok101kumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ALOK KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, IGIMS PATNA
Patna
BIHAR
800014
India |
| Phone |
7992454344 |
| Fax |
|
| Email |
alok101kumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VINOD KUMAR VERMA |
| Designation |
PROFESSOR |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, IGIMS PATNA
Patna
BIHAR
800014
India |
| Phone |
9473191875 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
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Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHEIKHPURA, PATNA 800014 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ALOK KUMAR |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY 1st FLOOR WARD BLOCK IGIMS SHEIKHPURA PATNA
Patna
BIHAR |
7992454344
alok101kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IGIMS, PATNA |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients of ASA phycial status i and ii
2.elective surgery of different types
3.general anaesthesia
4.patients willing to participate |
|
| ExclusionCriteria |
| Details |
1.patients refusal to participate
2.patients with traumatic brain injuries, memory impairments, psychosis, or known or suspected EEG abnormality
3.patients with neurological disorders
4.uncooperative patients
5.psychiatric patients
6.patients with chronic abuse of psychoactive medication
7.patients undergoing neurosurgery
8.patients who will not need post-operative ventilation
9.any intra-operative events which can delay extubation like hypotention requring inotrops massive blood loss or hypothermia |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time between discontinuation of anesthetic agents and extubation will be recorded as tracheal extubation time as primary outcome |
time of extubation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| heart rate, blood pressure, MAP, Spo2, Etco2, BIS and ETAG |
baseline and then at 15 minutes interval intra operative |
|
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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" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2020 |
| 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
|
plan to publish on completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The purpose of this study is to compare the BIS monitoring vs ETAG concentration so that we can compare the use of anaesthetic drugs,time to extubation etc. |