| CTRI Number |
CTRI/2022/03/040826 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
25/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the use of two drugs, Granisetron and Ondansetron, for the prevention of nausea and vomiting after surgical procedures under general anaesthesia with inhalational anaesthetic drugs |
|
Scientific Title of Study
|
A comparative study of intravenous Granisetron and Ondansetron for the prophylaxis of postoperative nausea and vomiting following surgical procedures under general anaesthesia using inhalational agents: A prospective randomized |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhangee Tiwari |
| Designation |
Junior Resident Doctor |
| Affiliation |
Peoples College of Medical Sciences & Research Centre,Bhanpur, Bhopal |
| Address |
Room No. 102,
Department of Anaesthesia
1st Floor, B Block,
Peoples Hospital,
Peoples College of Medical Sciences & Research Centre,
Bhanpur
Department Office
Department of Anaesthesia
1st Floor, B Block,
Peoples Hospital,
Peoples College of Medical Sciences & Research Centre,
Bhanpur
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9406815077 |
| Fax |
|
| Email |
drshubhangeetiwari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mahima Batra |
| Designation |
Professor |
| Affiliation |
Peoples College of Medical Sciences & Research Centre, Bhanpur, Bhopal |
| Address |
Room No. 102,
Department of Anaesthesia
1st Floor, B Block,
Peoples Hospital,
Peoples College of Medical Sciences & Research Centre,
Bhanpur
Department Office
Department of Anaesthesia
1st Floor, B Block,
Peoples Hospital,
Peoples College of Medical Sciences & Research Centre,
Bhanpur
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9752975418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhangee Tiwari |
| Designation |
Junior Resident Doctor |
| Affiliation |
Peoples College of Medical Sciences & Research Centre, Bhanpur, Bhopal |
| Address |
Room No. 102,
Department of Anaesthesia
1st Floor, B Block,
Peoples Hospital,
Peoples College of Medical Sciences & Research Centre,
Bhanpur
Department Office,
Department of Anaesthesia
1st Floor, B Block,
Peoples Hospital,
Peoples College of Medical Sciences & Research Centre,
Bhanpur
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9406815077 |
| Fax |
|
| Email |
drshubhangeetiwari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College of Medical Sciences, Bhopal, Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Peoples College of Medical Sciences Research Centre |
| Address |
Karond Bypass Rd, Peoples Campus, Bhanpur, Bhopal, Madhya Pradesh 462037 |
| 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 Shubhangee Tiwari |
OT Complex and Recovery Room |
Department of Anaesthesia
1st Floor, B Block,
Peoples Hospital,
Peoples College of Medical Sciences & Research Centre,
Bhanpur
Bhopal
MADHYA PRADESH |
9406815077
drshubhangeetiwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Peoples College of Medical Sciences, Bhopal , Registration No. ECR/519/Inst/MP/2014/RR-20 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (2) ICD-10 Condition: H701||Chronic mastoiditis, (3) ICD-10 Condition: K811||Chronic cholecystitis, (4) ICD-10 Condition: K565||Intestinal adhesions [bands] withobstruction (postinfection), (5) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
i.v. granisetron |
Granisetron is a serotonin 5-HT3 receptor antagonist that is used as an antiemetic to treat nausea and vomiting after chemotherapy or radiotherapy. Its primary function is to inhibit the activity of the vagus nerve, which activates the vomiting centre in the medulla oblongata. It is on the WHOs List of Essential Medicines. Granisetron is a medication that is well-tolerated and has few side effects. The most generally reported side effects of its use are headache, dizziness, and constipation. There have been no significant drug interactions reported with this drugs use. Patients will receive 2 mg granisetron single dose iv bolus before extubation. |
| Comparator Agent |
ONDANSETRON |
Studies have proved the benefit of intravenous granisetron in its adverse event profile and its long action when compared to the standard of care (intravenous ondansetron). But these studies are for certain specific subsets of patients undergoing certain surgical procedures. We plan to compare its safety and efficacy in a wide range of patients & disease profile undergoing surgery under general anaesthesia.Patients will receive 4mg ondansetron i.v. (SOC) i.v. single bolus dose before extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-Age 18yrs – 50 yrs
-ASA grades I and II
-Weighing more than 40 kg,
-Those scheduled under general anaesthesia using inhalational agents will be included in the study |
|
| ExclusionCriteria |
| Details |
a) Patients not giving consent
b) ASA grades III and IV patients.
c)Age < 18yrs and >50yrs.
d) Had taken antiemetic drugs within 24 hours before surgery.
e)Emergency surgeries & Full stomach
f)History of motion sickness or previous PONV
g)Total intravenous anesthesia |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy & safety of granisetron i.v. vs standard of care ondansetron i.v. in patients undergoing surgery under general anaesthesia. |
First 24 hours, grouped as 0-1 hours,1-3 hours,3-6 hours,6-12 hours,12-24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of these drugs on clinical recovery, based on episodes of vomiting and recovery time. Nausea not considered as a symptom for the secondary outcome. |
first 24 hours, post surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshubhangeetiwari@gmail.com].
- For how long will this data be available start date provided 30-11-2022 and end date provided 28-12-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
PONV occurs in up to 40% of all patients who receive GA with inhalational drugs without any prophylaxis, but it can be as high as 80% in high-risk individuals. 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have been demonstrated to be safe and effective in the prevention and treatment of PONV. Intravenous Ondansetron is the standard of care in this aspect. Though several studies have been undertaken to evaluate the preventive anti-emetic effects of these medicines in general anaesthesia, they have always been conducted on specific target groups with stringent inclusion and exclusion criteria. In this study, we will administer intravenous Granisetron (2mg, single dose) or Ondansetron (4mg, single dose) to patients before the end of surgery for the prophylaxis of post-operative nausea and vomiting following surgical procedure under general anaesthesia using inhalational agents in order to investigate the prophylactic anti-emetic efficacy and safety of intravenous Ondansetron and Granisetron
|