| CTRI Number |
CTRI/2018/01/011293 [Registered on: 12/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two different anti vomiting drugs in preventing injection pain of anesthesia inducing drug |
|
Scientific Title of Study
|
A comparative study of intravenous ondensetron and palonosetron as pretreatment to prevent pain on injection of propofol |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shamshuzoha M |
| Designation |
Resident |
| Affiliation |
Kempegowda Insitute of Medical Sciences |
| Address |
Department of Anesthesiology,
Fourth floor, Kempegowda Institute of Medical Sciences and Hospital, VV puram, Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9742131215 |
| Fax |
|
| Email |
shamshuzoha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhava Reddy R |
| Designation |
Professor |
| Affiliation |
Kempegowda Insitute of Medical Sciences |
| Address |
Department of Anesthesiology,
Fourth floor, Kempegowda Institute of Medical Sciences and Hospital, VV puram, Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9379094790 |
| Fax |
|
| Email |
madhavareddy.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shamshuzoha M |
| Designation |
Resident |
| Affiliation |
Kempegowda Insitute of Medical Sciences |
| Address |
Department of Anesthesiology,
Fourth floor, Kempegowda Institute of Medical Sciences and Hospital, VV puram,Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9742131215 |
| Fax |
|
| Email |
shamshuzoha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shamshuzoha. M,
Department of anaesthesiology, Fourth floor, Kempegowda Institute of Medical Sciences and Hospital, VV puram, Bangalore - 560004 |
|
|
Primary Sponsor
|
| Name |
Shamshuzoha M |
| Address |
#85/1, 4th cross Masjid road, Chamundeshwari nagara, Laggere, Bangalore North, Bangalore Peenya small Industries, Karnataka- 560058 |
| 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 |
| Shamshuzoha M |
Kempegowda Institute of Medical Sciences |
Kempegowda Institute of Medical Sciences Hospital and Research Centre, VV Puram, Bangalore- 560004
Bangalore
KARNATAKA |
9742131215
shamshuzoha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kempegowda Institute of Medical Sciences ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Laproscopic surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Ondensetron |
Single dose of 4mg Ondensetron diluted with normal saline to 4ml intravenous over one minute |
| Comparator Agent |
Injection palonosetron |
Single dose of 0.075mg Palonosetron diluted with normal saline to 4ml intravenous over one minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Posted for elective Laproscopic surgery under General anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with presence of infection on the dorsum of non-dominant hand
Patients with thin dorsal veins
Patients with known hypersensitivity to Propofol, Ondensetron and Palonosetron |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain during injection of Propofol
|
1, 3 and 5 minute after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative nausea and vomiting |
Noted for 24 hours Post operative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2014 |
| Date of Study Completion (India) |
30/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intravenous Propofol causes pain on injection, different drugs have been used to prevent Propofol injection pain 5HT3 receptor antagonist which are commonly used for prevention of nausea and vomiting are also used for having analgesic property. Different 5HT3 receptor antagonists were used as pretreatment in preventing this pain. In literature there are very minimal studies comparing Ondensetron and Palonosetron as pretreatment in preventing the Propofol injection pain.
The overall incidence of pain in group Ondensetron and group Palonosetron was 32% and 26% respectively. 4% of patient in group Ondensetron and 2% of patient in group Palonosetron complained of severe pain. Incidence of post operative nausea and vomiting in group Palonosetron (20%) was comparatively lower than group Ondensetron (38%). |