| CTRI Number |
CTRI/2017/03/007998 [Registered on: 03/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prevention of nausea and vomiting in middle ear surgery by Comparison of palonosetron & dexamethasone and ondansetron & dexamethasone combination |
|
Scientific Title of Study
|
Comparison of efficacy of palonosetron & dexamethasone and ondansetron & dexamethasone combination for prevention of postoperative nausea and vomiting in patients undergoing middle ear surgery- A randomized double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Version no- 1.0/ Date- 27/06/16 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishor Nagar Seepat road
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saima Khan |
| Designation |
DNB Student |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anesthesia Apollo Hospitals Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
|
| Fax |
|
| Email |
ahmadshakeel817@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
25 Parijat Raj Kishore Nagar
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
|
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Seepat road Lingiadih Village Bilaspur |
| 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 |
| Dr Vinit Kumar Srivastava |
Apollo Hospitals Bilaspur |
Department of
Anesthesia, Second
Floor, O T Complex
Bilaspur
CHHATTISGARH |
9755557539
drvinit75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur (CG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I and II, Non hypertensive and non diabetic
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ondansetron & Dexamethasone |
Ondansetron 8 mg and dexamethasone 8 mg intravenously prior to induction of anesthesia |
| Comparator Agent |
Palonosetron & dexamethasone |
Palonosetron 0.075mg and dexamethasone 8 mg intravenously prior to induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and II
2. Non hypertensive and non diabetic
|
|
| ExclusionCriteria |
| Details |
1.Known allergy to study drug
2.Use of antiemetic drugs 24 hours before surgery.
3.Morbid obesity (body mass index>40)
4.Chronic use of opioids
5.Diabetes and hypertension
6.Hepatic, renal or cardiovascular dysfunction
7.Psychiatric patients
8.Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of nausea and vomiting |
During postoperative period 0–2 hr, 2–6 hr and 6–24 h after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patients satisfaction score
Requirement of rescue antiemetic |
Satisfaction score 24 hr after surgery
Rescue antiemetic during 0-2 hr, 2-6 hr and 6-24 hr |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/08/2016 |
| Date of Study Completion (India) |
Date Missing |
| 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
Modification(s)
|
Study starts from 05/08/2016 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postoperative nausea and vomiting (PONV) is a common and distressing complication after middle ear surgeries. An incidence of up to 80% has been reported in literature undergoing middle ear surgery under general anesthesia. Various drugs have been used to prevent PONV. The 5-HT3 receptor antagonists are now a first line option because of effectiveness, more safety and favourable side effects profile. Ondansetron was the first 5-HT3 receptor antagonist. Palonosetron is the most recently introduced member of this class. It has unique chemical structure, the interaction pattern with the 5HT3 receptor is dfferent from earlier 5-HT3 receptor antagonists. Intravenous dexamethasone reduces the incidence of PONV by a central mechanism. Hence this study is designed to evaluate and compare the efficacy of palonosetron & dexamethasone and ondansetron & dexamethasone combination for prevention of PONV in middle ear surgery. All selected patients will be randomized in to 2 groups (30 in each group) depending on the drug given. Group O - Ondansetron (8mg) & Dexamethasone (8mg) I.V. prior to induction of anesthesia Group P - Palonosteron (0.075mg) & Dexamethasone (8mg) I.V. prior to induction of anesthesia
Primary outcome - Incidence and severity of nausea and vomiting Secondary outcome - Patient satisfaction score and requirement of rescue antiemetic
Statistical analysis will be done after completion of study. |