| CTRI Number |
CTRI/2025/02/080016 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative study |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to compare the 2 scoring systems in assessing recovery from general anaesthesia in patients undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
A Comparative study of Modified Aldrete score and
Fast-track criteria for assessing recovery from general anaesthesia in patients undergoing laparoscopic surgeries |
| 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 Priyanka D S |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Bangalore medical college and research institute, Bangalore |
| Address |
3rd floor , MPB building, department of anesthesiology, Victoria hospital, Banglore medical college and research institute, KR road fort , Banglore, Karnataka 560018
India
Bangalore
KARNATAKA
560018
India |
| Phone |
9880027712 |
| Fax |
|
| Email |
priyankadrs12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tulsi T |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute, Banglore |
| Address |
3rd floor , MPB building, department of anesthesiology, Victoria hospital, Banglore medical college and research institute, KR road fort , Banglore, Karnataka 560018
India
Bangalore
KARNATAKA
560018
India |
| Phone |
9483188870 |
| Fax |
|
| Email |
drtulsikeshav1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tulsi T |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute, Banglore |
| Address |
3rd floor , MPB building, department of anesthesiology, Victoria hospital, Banglore medical college and research institute, KR road fort , Banglore, Karnataka 560018
India
Bangalore
KARNATAKA
560018
India |
| Phone |
9483188870 |
| Fax |
|
| Email |
drtulsikeshav1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute Bangalore Karnataka -560002 |
|
|
Primary Sponsor
|
| Name |
Dr PRIYANKA D S |
| Address |
Post graduate student, department of anesthesiology , Bangalore medical college and research institute, Bangalore, Karnataka -560018 |
| 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 PRIYANKA D S |
Bangalore medical college and research institute, Bangalore |
3rd floor , MPB building, department of anesthesiology, Victoria hospital, Banglore medical college and research institute, KR road fort , Banglore, Karnataka 560018
India
Bangalore
KARNATAKA |
9880027712
priyankadrs12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing laparoscopic surgeries.
2.Patients aged between 18 to 65 years
3.Patients willing to give informed written consent
4. Patients with ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Patients refusal to give informed written consent 2.Patients with laparoscopic surgeries get converted to open abdominal surgeries 3.Patients with ASA grade 3 and more 4. Pregnant women 5. Patients with conditions causing delayed recovery from general anaesthesia like hypothyroidism, seizures, stroke, cognitive dysfunction, hepatic failure,renal failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to recovery from general anesthesia using modified aldrete scoring and fast track criteria |
Immediate postoperative period, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min , 2 hours , 6 hours , 12 hours, 24 hours after tracheal extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic monitoring |
Immediate postoperative period, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min , 2 hours , 6 hours , 12 hours, 24 hours after tracheal extubation |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
17/02/2025 |
| 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="1"
Months="0"
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
|
Pre anesthetic evaluation and selection of patients
Baseline measurement of vitals parameters and induction of anesthesia
Muscle relaxant given and tracheal intubation done
Maintenance with inhalational anesthestic agent and muscle relaxant intermittently
Monitoring of intraoperative vital parameters
Extubation once the surgery is completed after complete of reversal of neuromuscular blockade agents
Assessment of recovery from general anesthesia using modified aldrete score and fast track criteria in immediate postoperative period, every 5 minutes until 30 min , 2, 6,12,24 hours following tracheal extubation
Data analysis
|