| CTRI Number |
CTRI/2024/07/070312 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs in laproscopic surgeries for prevention of nausea and vomiting after surgery |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Ondansetron for prevention of post operative nausea and vomiting in laproscopic 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 Sanjay Johar |
| Designation |
Professor |
| Affiliation |
Pt BD Sharma post graduate institute of medical sciences |
| Address |
Dept of Anaesthesiology and Critical Care Pt BD Sharma post graduate institute of medical sciences
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416050652 |
| Fax |
|
| Email |
Sanjays321@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Junior Resident |
| Affiliation |
Pt BD Sharma post graduate institute of medical sciences |
| Address |
Dept of Anaesthesiology and Critical Care Pt BD Sharma post graduate institute of medical sciences
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7988467899 |
| Fax |
|
| Email |
zyxpooja6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Junior Resident |
| Affiliation |
Pt BD Sharma post graduate institute of medical sciences |
| Address |
Dept of Anaesthesiology and Critical Care Pt BD Sharma post graduate institute of medical sciences
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7988467899 |
| Fax |
|
| Email |
zyxpooja6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care, Pt BD Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS, Rohtak |
| Address |
Dept of Anaesthesiology and Critical Care Pt BD Sharma post graduate institute of medical sciences
Rohtak
Haryana
124001
India |
| 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 Pooja Yadav |
Pt BD Sharma PGIMS Rohtak |
Dept of Anaesthesiology and Critical Care Pt BD Sharma post graduate institute of medical sciences
Rohtak
Haryana
124001
India
Rohtak
HARYANA |
07988467899
zyxpooja6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dexmedetomidine 1mcg/kg in 100 ml Normal Saline over 15-20 minutes just after intubation in Laproscopic Surgeries |
| Comparator Agent |
Ondanstron |
ondansetron 4mg given in patient undergoing Laproscopic surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 or 2 scheduled for laprocopic surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Refusal to consent
History of motion sickness
Combined hepatic and renal disease
History of Parkinsonism
History of vertigo
Patient on Chemotherapy
ASA grade 3 or more
History of GERD
Any history of Vomiting |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Dexmedetomidine and Ondansetron for prevention of postoperative nausea and vomiting in laparoscopic surgeries. |
Post operative nausea and vomiting will be assessed at 0hour,4hour,12hour post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in hemodyanamics intraoperatively and in post operative room |
Mean Blood Pressure and pulse rate noted at time of induction ,5min,10 min,15 min ,30min,45min,1hr of Surgery and in post operative room |
| postoperative sedation |
at 0 hr,4hr, 12hr post syrgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/07/2024 |
| 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="1"
Months="1"
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
|
The present prospective study will be conducted in the department of anaesthesia and critical care, PGIMS, Rohtak. Written informed consent will be taken from patients included. Comparison of Dexmedetomidine and Ondansetron will be done in Laparoscopic surgeries for prevention of nausea and vomiting. Data will be Compiled and analysed with appropriate statistical test. |