| CTRI Number |
CTRI/2020/03/024340 [Registered on: 30/03/2020] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between effect of BIS and MAC monitoring on recovery profile of patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison between effect of bispectral index and minimum alveolar anaesthetic concentration monitoring on recovery profile in patients undergoing general anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Abhijit Bagle Girwalkar |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Medical College,Pimpri, Pune |
| Address |
Dept of anaesthesia
Dr D Y Patil Medical college
Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
aparna.bagle@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Abhijit Bagle Girwalkar |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Medical College,Pimpri, Pune |
| Address |
Dept of anaesthesia
Dr D Y Patil Medical college
Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
aparna.bagle@dpu.edu.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Aparna Abhijit Bagle Girwalkar |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Medical College,Pimpri, Pune |
| Address |
Dept of anaesthesia
Dr D Y Patil Medical college
Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
aparna.bagle@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College,Pimpri,Pune |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Abhijit Bagle Girwalkar |
| Address |
Dept of anaesthesia
Dr D Y Patil Medical College.Pimpri,Pune |
| 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 Aparna Abhijit Bagle Girwalkar |
Dept of anaesthesia |
Dr D Y Patil,Medical College,Pimpri,Pune
Pune
MAHARASHTRA |
9834430811
aparna.bagle@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee-Dr.D.Y.Patil Vidypeeth |
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 |
| Comparator Agent |
effect of BIS Monitoring on recovery profile in patients undergoing general anaesthesia |
BIS value will be maintained between 40 to 60 from 15 min after induction of anesthesia till the end of surgery,then recovery profile will be recorded in terms of Time to eye opening,time to extubation and any recall after sugery |
| Intervention |
Comparison between effect of bispectral index and minimum alveolar anaesthetic concentration monitoring on recovery profile in patients undergoing general anesthesia |
bis and mac monitoring in respective groups |
| Comparator Agent |
effect of MAC Monitoring on recovery profile in patients undergoing general anaesthesia |
MAC value will be maintained between 0.7 to 1.3 from 15 min after induction of anesthesia till the end of surgery,then recovery profile will be recorded in terms of Time to eye opening,time to extubation and any recall after sugery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with physical status asa 1 and 2 posted for surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
patietns with pyschiatric illness, clinically significant cardiovascular, respiratory, hepatic,neurological,long term drug therapy or alcohol abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the effect of BIS or MAC monitoring on recovery profile of patients unergoing general anaesthesia |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any perioperative complications or recall of intra operative events |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
31/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Bagle A, Hasnain S, Suryawanshi C. Comparison between the effect of bispectral index and minimum alveolar concentration monitoring on recovery after general anesthesia: a prospective, randomized, clinical study. Bali J Anaesthesiol 2023;7:224-9
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study was conducted to investigate the effect of bispectral index (BIS) monitoring
compared to the minimum alveolar anesthetic concentration (MAC) monitoring on recovery of patients undergoing isofluranebased general anesthesia. Materials and Methods: A total of 62 patients were randomly allocated to group B (BIS-guided) and group
M (MAC-guided). Along with clinical hemodynamic monitoring for titration of isoflurane in group B, BIS was monitored and
maintained between 40 and 60, whereas in group M, MAC was maintained between 0.7 and 1.3. The recovery profile was studied
in terms of time to eye-opening, time to extubation, and time to achieve the modified Aldrete score ≥9 in both groups. Patients
were followed up for any postoperative side effects and awareness during general anesthesia. Results: Group B and group M were
comparable with respect to age, gender, duration of surgery, duration of anesthesia, and type of surgery. Median time to eye-opening
was 4min in group B and 5min in group M (P < 0.001). The time to extubation was 8min in group B, compared to 11min in group M
(P < 0.001). Furthermore, the time needed to achieve the modified Aldrete’s score of ≥9 was also shorter in group B (P < 0.001). No
patients reported awareness during anesthesia. Conclusion: The use of BIS monitoring hastens the extubation and recovery in patients
undergoing general anesthesia |