| CTRI Number |
CTRI/2015/09/006223 [Registered on: 29/09/2015] Trial Registered Prospectively |
| Last Modified On: |
17/01/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of palanosetron and dexamethasone with ondansetron and dexamethasone for prevention of nausea and vomiting after operation in cancer patients receiving opioid based pain relief medicine |
|
Scientific Title of Study
|
Comparison of Palanosetron and Dexamethasone with Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting in post chemotherapy patients undergoing ovarian cancer surgery receiving opioid based intravenous patient controlled analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kailash Sharma |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Parel, Mumbai (India) |
| Address |
Department of Anaesthesiology, Critical Care and Pain
2nd floor, Main Building
Tata Memorial Hospital
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09821161087 |
| Fax |
02224146937 |
| Email |
rashmikailashsharma@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital, Parel, Mumbai (India) |
| Address |
Department of Anaesthesiology, Critical Care and Pain
2nd floor, main building
Tata Memorial Hospital
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09869158689 |
| Fax |
02224146937 |
| Email |
amit2007kr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kumar |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital, Parel, Mumbai (India) |
| Address |
Department of Anaesthesiology, Critical Care and Pain
2nd floor, main building
Tata Memorial Hospital
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09869158689 |
| Fax |
02224146937 |
| Email |
amit2007kr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Kailash Sharma |
Tata Memorial Hospital |
Room No. MB-210, Operation Theatre Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, parel, Mumbai-400012, India
Mumbai
MAHARASHTRA |
09821161087
02224146937
rashmikailashsharma@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cancer patients posted for ovarian cancer surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ondasetron and dexamathasone |
Ondasetron (8 mg) and dexamathasone (4 mg) will be given in operation theatre at the time of wound closer and there after Ondansetron 4 mg will be given three times a day for 48 hours |
| Intervention |
Palonosetron and dexamethasone |
Palonosetron (0.075 mg) and dexamethasone (4mg) will be given in operation theatre at the time of wound closer and there after placebo drug will be given three times a day for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
18-70 years old female patients, American Society of Anaesthesiologist class I and II, Post chemotherapy patients undergoing open ovarian cancer surgery and requiring opioid based patient controlled analgesia |
|
| ExclusionCriteria |
| Details |
1. American Society of Anaesthesiologist class III and above,
2. Smokers
3. Cognitive impairment or an active psychiatric condition
4. Patients with known liver and kidney diseases,
5. History of a palanosetron/ ondansetron/ dexamethasone or fentanyl allergy
6. Use of corticosteroids, psychoactive drugs or any other medication with known emetic or
antiemetic effect within 24 hrs prior to surgery
7. History of opioid abuse.
Extended Exclusion Criteri
1. Patients who will be shifted to intensive care unit on endotracheal tube for post operative mechanical ventilation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The overall incidence of Post Operative Nausea and Vomiting between the Ondasetron with dexamethasone and Palonosetron with dexamathasone groups. |
Every half an hour for first 2 hours and after that at intervals of 2 to 6, 6 to 24, 24 to 48 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison ofintensities of nausea, pain, cumulative dose of opioid, rescue analgesics and antiemetic requirements, discontinuation of opioid ahead of time, and adverse events |
Every half an hour for first 2 hours and after that at intervals of 2 to 6, 6 to 24, 24 to 48 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2015 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postoperative nausea and vomiting (POVN) is considered one of the most unpleasant postoperative discomforts and leads to serious complications of aspiration of gastric contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The incidence of PONV is 30-40% in normal populations and touches a peak of 75-80% in certain high-risk groups.The use of opioid-based intravenous-patient controlled analgesia (IV-PCA) for controlling postoperative pain has become widespread. Yet while IV-PCA is effective in controlling postoperative pain, continuous administration of opioid can cause or aggravate PONV. PONV is the most common reason why patients choose to stop IV-PCA. Ondansetron is the first 5-HT3 antagonist, used alone or in combination for the prophylaxis due to its lower cost. Palonosetron is a second generation 5-HT3 antagonist with a unique chemical structure and longer half- life of 40 hours. It is found to be very effective in chemotherapy induced nausea and vomiting as well as PONV. Dexamethasone with a 5-HT3 antagonist is an attractive combination, because ondansetron is most effective against early vomiting, whereas dexamethasone is effective against both early and late (2–24 h) nausea and vomiting, its late efficacy being pronounced.
|