| CTRI Number |
CTRI/2024/04/065741 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of Ondansetron and Palonosetron in reducing post-surgery nausea and vomiting for patients undergoing general anesthesia. |
|
Scientific Title of Study
|
Comparative study between Ondansetron and Palonosetron in prevention of Postoperative nausea vomiting under general anaesthesia -Double blinded randomised control study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lahari priya Vempuluru |
| Designation |
DNB Resident |
| Affiliation |
Dr Rangarajan Memorial Hospital (Sundaram medical foundation) |
| Address |
Operation theatre, 1st floor Department of Anaesthesia Dr Rangarajan Memorial Hospital Anna Nagar Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
8978123299 |
| Fax |
|
| Email |
laharipriyagoud30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasikala |
| Designation |
Senior consultant, Department of Anaesthesia |
| Affiliation |
Dr Rangarajan Memorial Hospital |
| Address |
Operation theatre,1st floor Department of Anaesthesia Dr Rangarajan Memorial Hospital Anna Nagar Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
9940666716 |
| Fax |
|
| Email |
drsasi123@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lahari priya |
| Designation |
DNB RESIDENT |
| Affiliation |
Dr Rangarajan Memorial Hospital |
| Address |
Operation theatre,1st floor Department of Anaesthesia Dr Rangarajan Memorial Hospital Anna Nagar Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
8978123299 |
| Fax |
|
| Email |
laharipriyagoud30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation)9C, 4th Ave, AH Block, Shanthi Colony, Anna Nagar, Chennai, Tamil Nadu 600040 |
|
|
Primary Sponsor
|
| Name |
DR LAHARI PRIYA VEMPULURU |
| Address |
Flat no:9 Honey dew apartment Kilpauk Chennai Tamilnadu 600010 |
| Type of Sponsor |
Other [This is post graduate thesis study ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rangarajan Memorial Hospital Sundaram Medical Foundation |
Shanthi colony 4th Avenue Anna Nagar Chennai Tamilnadu 600040 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR LAHARI PRIYA VEMPULURU |
Dr Rangarajan memorial hospital ( Sundaram Medical Foundation) |
Department of Anaesthesia Operation theatre OT 1 OT 2 OT 3 First floor Shanthi colony Anna Nagar Chennai 600040
Chennai
TAMIL NADU |
8978123299
laharipriyagoud30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sundaram Medical Foundation[Dr. Rangarajan Memorial Hospital] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ONDANSETRON GROUP |
Patients enrolled in group A will receive an injection of Ondansetron 4mg in 2 ml dilution slow I.V. over 10 minutes by an anesthesiologist not involved in the postoperative monitoring of the patient before induction of general anesthesia. The principal investigator and patient will be blinded to the test drug |
| Intervention |
PALONOSETRON GROUP |
Patients enrolled in group B will receive an injection of palonosetron 0.075mg in 2 ml dilution slow I.V. over 10 minutes by an anesthesiologist not involved in the postoperative monitoring of the patient before induction of general anesthesia. The principal investigator and patient will be blinded to the test drug. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- ASA physical status I, II
- Between 18 to 65 yrs. of age.
- Both genders
|
|
| ExclusionCriteria |
| Details |
Patient refusal
- Allergic to study drugs
- Pregnant women
- History of motion sickness, acid peptic disease
- Patients on any anti emetics 24hrs prior to surgery |
|
|
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 |
| Complete response assessed by incidence of nausea ,vomiting and use of rescue anti emetics |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Patient satisfaction
2) Side effects - headache, dizziness. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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 3 |
|
Date of First Enrollment (India)
|
23/04/2024 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a double blind randomised controlled trial to compare the efficacy of Palonosetron and Ondansetron in preventing PONV in patients undergoing general anaesthesia. Primary outcome of the study will be complete response assessed by incidence of nausea, vomiting and use of rescue anti emetics. Secondary outcomes of the study will be to assess patient satisfaction and side effects.This study help us to know which anti emetic is better in preventing post operative nausea and vomiting.The information we get may help us to treat future patients. |