| CTRI Number |
CTRI/2015/03/005616 [Registered on: 10/03/2015] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2015 |
| 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
|
COMPARISON OF TWO DRUGS FOR PREVENTION OF NAUSEA AND VOMITING IN PATEINTS UNDERGOING SURGERY FOR BRAIN TUMOURS |
|
Scientific Title of Study
|
COMPARISON OF PALANOSETRON AND ONDANSETRON ON ONSET OF POSTCRANIOTOMY NAUSEA AND VOMITING (POO-PCNV) TRIAL |
| Trial Acronym |
POO-PCNV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HEMANT BHAGAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
PGIMER
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9216387387 |
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HEMANT BHAGAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
PGIMER
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9216387387 |
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HEMANT BHAGAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
PGIMER
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9216387387 |
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
PGIMER, SEC 12 CHANDIGARH |
| 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 HEMANT BHAGAT |
PGIMER |
DEPARTMENT OF ANAESTHTESIA AND INTENSIVE CARE, 5 TH FLOOR, NEHRU HOSPITAL, PGIMER,SEC 12, CHANDIGARH
Chandigarh
CHANDIGARH |
9216387387
hembhagat@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITEE(INTRAMURAL) POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
post operative nausea and vomiting in the neurosurgical patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ondansetron |
Most commonly used HT3 receptor antagonist, 4 mg intravenous will be given at the time of the dural closure |
| Comparator Agent |
Palanosetron |
New 5-HT3 Receptor antgonist, longer duration of action, safe profile, 0.075 mg intravenous will be given at the time of the dural closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Patients scheduled for elective intracranial surgery
• American Society of Anaesthesiologists (ASA) Grade I and II patients
• Patients with Glasgow Coma Scale (GCS) of 15
|
|
| ExclusionCriteria |
| Details |
• Patients with history of motion sickness
• Pregnant patients
• Breast feeding
• Allergy to palanosetron
• Morbid obesity
• Cardiac dysrhythmias
• Psychiatric illness
• Chronic smokers
• Those who have undergone ventriculo-peritoneal shunt
|
|
|
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 |
Comparison of time duration for onset of PONV in neurosurgical patients following craniotomy with use of palanosetron when compared to ondansetron .
|
0 hr, 1 hr,6 hr,12 hr,24 hr,36 hr,48 hr,72 hrs .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of palanosetron with ondansetron for - a) PONV scoring , b) incidence and severity of nausea, c) incidence of vomiting, d) length of postoperative hospital stay, e) side effects and f) patient satisfaction. |
0 hr, 1 hr,6 hr, 12 hrs, 24 hrs, 36 hrs, 48 hrs,72 hrs |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/06/2014 |
| 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="3"
Months="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PONV( Post operative nausea and vomiting) is a frequent and distressing symptom after any type of neurosurgial procedure with a reported incidence of 44-70% in diffrent studies.In addition to cuasing patient discomfort protracted PONV causes dehdration, acid-base disturbance, electrolyte imbalance which may effect the cerebral physiology and influence the outcome of the patient. Selective serotonin(5HT-3) antagonists are considered first choice for PONV owing to their safe profile and lack of serious side effects. Palanosetron have been found to be superioir to other serotonin anatgonists in phase 3 clinical trials in reducing early, immediate and delayed chemotherapy induced vomiting. No study has yet been done to evaluate the efficacy of palanosetron in the neurosurgical pouplation. Thus we planned a prospetive randomized, double blind , controlled clinical trial to compare the efficacy of ondansetron and palanosetron in reducing PONV in patients undergoing neurosurgery. We will also assess corerelation of PONV with other factors sich as midline shift, mass effect, site and pathologic diagnosis of the tumour.
|