| CTRI Number |
CTRI/2017/11/010507 [Registered on: 15/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two drugs, dexamethasone and granisetron in their ability to prevent vomiting after surgery in women |
|
Scientific Title of Study
|
Double blinded randomized controlled study to compare the efficacy of dexamethasone with granisetron in prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth Ganesan |
| Designation |
Junior Resident, 3rd Year |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, No.1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
ganesanprashanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aruna Parameswari |
| Designation |
Professor and Guide |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, No.1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
reetharun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aruna Parameswari |
| Designation |
Professor and Guide |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, No.1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
reetharun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, No.1, Ramachandra Nagar, Porur, Chennai - 600116, Tamil Nadu, INDIA |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Medical College and Research Institute |
| Address |
Department of Anesthesiology, Sri Ramachandra University, No.1, Ramachandra Nagar, Porur, Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prasanth Ganesan |
Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University |
A6, Department of Anaesthesiology, No.1, Ramachandra Nagar, Porur, Chennai - 600116
Chennai
TAMIL NADU |
04423860830
ganesanprashanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra University Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Postoperative nausea and vomiting in female patients undergoing elective laparoscopic surgery , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Dexamethasone 8 mg administered intravenously at the time of induction of anesthesia |
| Comparator Agent |
Granisetron |
Granisetron 3 mg administered intravenously at the time of induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
ASA I and II
Female patients undergoing elective laparoscopic procedures
Non pregnant |
|
| ExclusionCriteria |
| Details |
Emergency surgery
ASA III and above
Patients with preoperative vomiting
BMI greater than 30
History of steroid use
Patients with contraindication to study drugs
Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PONV intensity score |
6h, 12h, 18h, 24h, 72h after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of first rescue antiemetic administration, total postoperative metoclopramide consumption |
24h, 72h after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2016 |
| Date of Study Completion (India) |
07/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Dalvi N, Chimalwar S. Int J Sci Res.2016;5:132-136. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This was a prospective, randomized study to compare the antiemetic efficacy of dexamethasone 8 mg given intravenuously with granisetron 3 mg intravenously for elective laparoscopic surgery in women. Our hypothesis was that dexamethasone given intravenously prior to induction of anesthesia is a better antiemetic than granisetron.
There was no statistically significant difference in the PONV intensity scores between the two groups at all time points of assessment (p>0.05 at all times assessed). There was no statistically significant difference in the consumption of rescue antiemetic metoclopramide between the two groups (p=0.741) |