| CTRI Number |
CTRI/2023/01/049153 [Registered on: 23/01/2023] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARATIVE STUDY BETWEEN OPIOID BASED ANESTHESIA AND OPIOID FREE ANESTHESIA ON VARIOUS INTRAOPERATIVE AND POSTOPERATIVE PARAMETRRS. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF CONVENTIONAL OPIOID BASED ANAESTHESIA AND OPIOID-SPARING ANAESTHESIA IN PATIENTS UNDERGOING LAPROSCOPIC SURGERIES. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajakta Vetal |
| Designation |
Post graduate |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Lighthouse Hill road, Hampankatta, Mangalore
Kasturba Medical College, Lighthouse Hill road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9673334110 |
| Fax |
|
| Email |
vetal.prajakta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumesh T Rao |
| Designation |
Professor and Head of department |
| Affiliation |
Kasturba Medical College, Department of anesthesia Mangalore |
| Address |
Kasturba Medical College, Department of Anesthesia Lighthouse Hill road, Hampankatta, Mangalore
Kasturba Medical College, Lighthouse Hill road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449167895 |
| Fax |
|
| Email |
drstrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prajakta Vetal |
| Designation |
Post graduate |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Lighthouse Hill road, Hampankatta, Mangalore
Kasturba Medical College, Lighthouse Hill road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9673334110 |
| Fax |
|
| Email |
vetal.prajakta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Lighthouse Hill road, Hampankatta, Mangalore |
| Type of Sponsor |
Private 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 |
| Prajakta Vetal |
Kasturba Medical College and hospital, Mangalore |
Department of Anaesthesiology Kasturba Medical College Mangalore, 575003
Dakshina Kannada
KARNATAKA |
9673334110
vetal.prajakta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Medical College, Mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing laparoscopic surgeries.
Patients belonging to American Society of Anaesthesiologists (ASA) grades 1 and 2
|
|
| ExclusionCriteria |
| Details |
Uncooperative / unwilling
≥ ASA 3
body mass index > 35 kg/m2
patients having liver and renal insufficiency
Conversion to open technique and continuation of post-operative ventilation
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score at different post-operative time intervals. |
Pain score at 0 hrs, 2 hrs, 6 hrs and 24 hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra-operative haemodynamic parameters
Post-operative haemodynamic parameters
Post-operative nausea and vomiting
Patient satisfaction
|
0 hrs, 2 hrs, 6 hrs, 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2023 |
| Date of Study Completion (India) |
12/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare opioid‑free anaesthesia with opioid‑based technique for post‑operative pain relief in laparoscopic surgeries. To assess the pain scores in the post‑operative period for 24 h.
To compare intra-operative haemodynamic parameters,
To assess duration of postoperative analgesia and recovery and patient satisfaction after anesthesia.
|