| CTRI Number |
CTRI/2024/10/075436 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare sevoflurane consumption and time to tracheal extubation by using bispectral index monitoring versus end-tidal agent concentration monitoring in patients undergoing sevoflurane based general anaesthesia.
|
|
Scientific Title of Study
|
Randomised Comparative Study On Sevoflurane Consumption And Time To Tracheal Extubation By Using Bispectral Index Monitoring Versus End-Tidal Agent Concentration Monitoring In Patients Undergoing Sevoflurane Based General Anaesthesia, At S.M.S Medical College Jaipur |
| 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 Siddhartha Sharma |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004 India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829950020 |
| Fax |
|
| Email |
drsiddharthasharma@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Sharma |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004 India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829950020 |
| Fax |
|
| Email |
drsiddharthasharma@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandu S Meppallil |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College And Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004 India
Jaipur
RAJASTHAN
302004
India |
| Phone |
7509621511 |
| Fax |
|
| Email |
meppallilanandu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Sawai Man Singh Medical College And Attached Hospitals, Jaipur , Rajasthan , India pin :302004 |
|
|
Primary Sponsor
|
| Name |
Department of AnaesthesiologySawai Man Singh Medical College And Attached Hospitals Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Siddhartha Sharma |
Sawai Man Singh Medical College and Attached Hospitals |
Urology ot 6th floor , Superspeciality building , SMS Medical College And Attached Hospitals, JLN Marg, Adarsh Nagar, Jaipur Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9829950020
drsiddharthasharma@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College And Attached Hospitals. Jaipur |
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 |
Bispectral index is developed from a processed electroencephalogram and used in anaesthetised patients, has been shown to decrease the incidence of post-operative recall for intra operative awareness when maintained below 60. |
| Comparator Agent |
End-Tidal Agent Concentration |
ETAG concentration criteria relates to brain activity through concentration of anesthetic agent expired in lungs assuming it to be in equilibrium with brain concentration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective urology surgery under Sevoflurane based general anaesthesia between 60-120 minutes. ASA grade I & II.Patients with BMI less than 30 kg per meter squared |
|
| ExclusionCriteria |
| Details |
1.Patients with history of long term use of psychoactive and anticonvulsant medications.
2.Patients with psychiatric illness, known or suspected electroencephalographic abnormalities (EEG).
3.Patients with pre existing renal or hepatic diseases.
4.Patients with preexisting pulmonary diseases.
5.Patients with pre existing cardiac diseases.
6. Patients with anticipated difficult airway
7.Patients with dementia and stroke with residual neurological deficits. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine and compare the time to tracheal extubation under Sevoflurane based anaesthesia between BIS and ETAC monitoring.
2.To determine and compare the sevoflurane consumption in patients undergoing sevoflurane based general anesthesia between BIS and ETAC monitoring . |
From baseline to completion of surgery every 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine and compare recovery time under Sevoflurane based anaesthesia between BIS and ETAC monitoring .
2.To determine and compare the change in the hemodynamic parameters (HR,SBP,MAP and SpO2 )in both groups. |
120 minutes |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
21/10/2024 |
| 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="0"
Months="3"
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
|
Maintaining an optimal depth of anaesthesia during surgery is essential toprevent awareness and to ensure a rapid , smooth recovery. Clinical parameters like Heart rate , BP , increased secretions or movement are subjective and thus not reliable for assessing the depth if anaesthesia .Bispectral index(BIS) is developed from a processedelectroencephalogram and used in anaesthetised patients, has been shown to decrease theincidence of post-operative recall for intra operative awareness when maintained below 60. |