| CTRI Number |
CTRI/2013/03/003507 [Registered on: 21/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
21/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
ondansetron (drug preventing vomiting) strip versus intravenous injection for ear and nose surgeries after operation |
|
Scientific Title of Study
|
Ondansetron, orally disintegrating film versus intravenous injection for prevention of post operative nausea vomiting in middle ear and nasal surgeries- A randomized, placebo controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Ambi |
| Designation |
Assistant professor |
| Affiliation |
S Nijalingappa Medical college |
| Address |
Department of anesthesiology
S N medical college, Bagalkot
Karnataka.
Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
08354235400 |
| Fax |
|
| Email |
udayambi@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Ambi |
| Designation |
Assistant professor |
| Affiliation |
S Nijalingappa Medical college |
| Address |
Department of anesthesiology
S N medical college, Bagalkot
Karnataka.
Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
08354235400 |
| Fax |
|
| Email |
udayambi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Ambi |
| Designation |
Assistant professor |
| Affiliation |
S Nijalingappa Medical college |
| Address |
Department of anesthesiology
S N medical college, Bagalkot
Karnataka.
Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
08354235400 |
| Fax |
|
| Email |
udayambi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
S N medical college Bagalkot Karnataka |
| Address |
S N medical college, Bagalkot
Karnataka.
|
| Type of Sponsor |
Private 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 Uday Ambi |
Department of anaesthesia |
Department of anesthesiology
S N medical college, Bagalkot
Karnataka.
Bagalkot
KARNATAKA |
08354235400
udayambi@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee, S N Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
surgery induced nausea vomiting, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
normal saline/ placebo film |
placebo film or 2ml normal saline intravenous injection at the end of the surgery, single dose |
| Intervention |
ondansetron |
8mg ondansetron orally disintegrating film, single dose at the end of the surgery |
| Intervention |
ondansetron |
intravenous 8mg ondansetron, single dose at the end of the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
elective middle ear and nasal surgeries under monitored anaesthesia care |
|
| ExclusionCriteria |
| Details |
raised serum urea and creatinine, advanced liver disease, history of chronic use of sedatives, narcotics or both, history of alcohol or drug abuse, or allergy to any of the study medications. Patients with history of motion sickness or PONV and refusal for inclusion in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in incidence of post operative nausea vomiting |
2, 6, 12, 18, and 24 h postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of post operative pruritus |
2, 6, 12, 18, and 24 h postoperatively |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2013 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The incidence of post operative nausea and vomiting (PONV) is variable & depends on the patient, as well as type of anaesthesia and surgery. The incidence of PONV after middle ear & nasal surgeries has been reported to be 35-80 %. Ondansetron, a 5HT3 receptor antagonist, has been shown to be an effective prophylactic drug when administered either IV or orally in the form of orally disintegrating tablets. Orally disintegrating film (ODF) formulations are relatively recent innovations in drug administration. This study aims to evaluate the effects of Ondansetron ODF on the incidence of PONV in adult patients undergoing middle ear and functional endoscopic sinus surgeries done under monitored anaesthesia care and to evaluate whether these findings can be extrapolated to its use in day care ear and nasal surgeries. |