| CTRI Number |
CTRI/2019/08/020923 [Registered on: 27/08/2019] Trial Registered Prospectively |
| Last Modified On: |
05/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study which determines if Dexamethasone reduces vomiting after laproscopic gall bladder removal surgery. |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE ROLE OF DEXAMETHASONE IN PROPHYLAXIS OF POST OPERATIVE NAUSEA AND VOMITING IN LAPROSCOPIC CHOLECYSTECTOMY |
| Trial Acronym |
Dexamethasone In PONV |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tarang Jain |
| Designation |
Assistant Professor |
| Affiliation |
ESI PGIMSR |
| Address |
ESI PGIMSR
Basaidarapur
new delhi
Basaidarapur
New Delhi
North West
DELHI
110015
India |
| Phone |
98111827264 |
| Fax |
|
| Email |
dr.tarang@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarang Jain |
| Designation |
Assistant Professor |
| Affiliation |
ESI PGIMSR |
| Address |
ESI PGIMSR
Basaidarapur
new delhi
Basaidarapur
New Delhi
North West
DELHI
110015
India |
| Phone |
98111827264 |
| Fax |
|
| Email |
dr.tarang@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarang Jain |
| Designation |
Assistant Professor |
| Affiliation |
ESI PGIMSR |
| Address |
ESI PGIMSR
Basaidarapur
new delhi
Basaidarapur
New Delhi
North West
DELHI
110015
India |
| Phone |
98111827264 |
| Fax |
|
| Email |
dr.tarang@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ESI PGIMSR |
| Address |
Basaidarapur
New Delhi |
| 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 Tarang Jain |
ESI PGIMSR |
Room No 4, Second Floor OT Block Department of Anaesthesiology, Basaidarapur
West
DELHI |
98111827264
dr.tarang@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, ESI PGIMSR Basaidarapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Dexamethasone is given to patients at the beginning of the surgery to determine the incidence of post operative nausea and vomiting |
| Comparator Agent |
Ondensetron |
This is used as the comparator agent in determining the incidence of post operative nausea and vomiting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Class 1-2
2. Patients undergoing elective laproscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients who are pregnant or who have uncontrolled diabetes, glaucoma (all patients had blood glucose concentrations checked to exclude undiagnosed hyperglycaemia).
3. Those with a known adverse reaction to dexamethasone or who were taking any systemic steroids (excluding steroid inhalers, suppositories, pessaries, eye drops, one-off local injections to a joint, or topical preparations) were excluded from the trial. 4. Patients previously taking regular oral or intravenous steroids had to have stopped taking these drugs at least three months before trial entry to be eligible.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine if there any difference in post operative Nausea nad Vomiting when Dexamethasone is used in elective laproscopic cholecystectomy under general anaesthesia |
0, 2, 6, 12 and 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To determine difference in intra operative pain by using hemodynamic parameters
• To determine difference in post operative pain by using the Visual Analogue Scale.
• To determine difference in incidence of post operative sore throat.
|
Hemodynamic parameters shall be recorded every 15 minutes intra operatively.
0 hour, 2 hour, 6 hour, 12 hour and 24 hours post operative |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2019 |
| Date of Study Completion (India) |
30/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Long is among the most common complications after surgery, affecting more than 30% of patients. It is reported by patients to be among the top five undesirable outcomes. A systematic review has shown laproscopic surgery and increasing duration of surgery as independent predictors of PONV. Dexamethasone is a corticosteroid that influences patient outcome. It has been assesed in prevention of PONV in intermediate and low risk surgery. Post operative pain is a main reason for delayed discharge. Opiods are ttraditionally used for acute post operative pain relief but can lead to side effects like nausea and vomiting and itching. Co analgesic drugs reduce the amount of opiods needed. Dexamethasone has been evaluated as a co analgesic due to it`s anti inflammatory effect as well as effect on pain pathway. We aim to asses the effect of Dexamethasone on post operative nausea and vomiting and post operative pain medicine requirement. |