| CTRI Number |
CTRI/2021/10/037517 [Registered on: 25/10/2021] Trial Registered Prospectively |
| Last Modified On: |
21/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to determine the effect of ondansetron in prevention of hypotension in caesarean delivery under spinal anaesthesia |
|
Scientific Title of Study
|
Effect of prophylactic intravenous ondansetron in the prevention of spinal anaesthesia induced hypotension during caesarean delivery-A prospective randomized double blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monisha Ravichandran |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of Anaesthesiology
Udayar main block
Sri Ramachandra Institute Of Higher Education And Research,
Porur,
Chennai.
Department of Anaesthesiology
Udayar main block
Sri Ramachandra Institute Of Higher Education And Research,
Porur,
Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9442461287 |
| Fax |
|
| Email |
m2320012@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Vakamudi |
| Designation |
Professor and Guide |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute Of Higher Education And Research,
Porur,
Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
vakamudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Vakamudi |
| Designation |
Professor and Guide |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of Anaesthesiology,
Sri Ramachandra Institute Of Higher Education And Research,
Porur,
Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
vakamudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research,Porur,Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Dr Monisha Ravichandran |
| Address |
Sri Ramachandra Institute Of Higher Education And Research,
Porur,
Chennai 600116 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Monisha Ravichandran |
Sri Ramachandra Institute Of Higher Education And Research |
OBSTETRICS AND GYNAECOLOGY OPERATION THEATRE COMPLEX,
DEPARTMENT OF ANAESTHESIOLOGY,
THIRD FLOOR,
UDAYAR BLOCK AND G BLOCK
Chennai
TAMIL NADU |
9442461287
m2320012@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ONDANSETRON |
ONDANSETRON 4mg,intravenous 5 minutes before starting the study
ONDANSETRON 8mg,intravenous 5 minutes before starting the study |
| Comparator Agent |
PLACEBO |
Normal saline,intravenous 5 minutes before starting the study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)Parturients aged 18 to 45 years
2)American Society Of Anesthesiologits physical status less than III
3)Singleton term pregnancy(more than 37 weeks gestation)
4)Scheduled for elective caesarean delivery under regional anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)Hypersensitivity to Ondansetron
3)Contraindication for spinal anesthesia
4)Hypertensive disorders and diabetes with pregnancy
5)History of nausea,vomiting during the 24 hours before induction of anaesthesia
6)Multiple gestation
7)Patient receiving selective serotonin reuptake inhibitor
|
|
|
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 |
| To estimate the magnitude of the effect of Ondansetron versus placebo in reducing the incidence of spinal anaesthesia induced hypotension during caesarean delivery |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The requirement of phenylephrine,ephedrine and atropine.
|
1 Year |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/11/2021 |
| 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
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to determine the effect of Ondansetron in two different doses on the haemodynamic changes associated with spinal block and to estimate the requirement of vasopressors in preventing hypotension with the two different doses of Ondansetron in comparison with placebo in patients undergoing elective caesarean delivery.Consenting parturients aged between 18 to 45 years,ASA less than III,singleton term pregnancy scheduled for elective caesarean delivery under regional anaesthesia will be randomly allocated into three groups.Group A:patients will receive 4mg of of Ondansetron with 8ml of normal saline.Group B:patients will receive 8mg of Ondansetron with 6ml of normal saline.Group C:patients will receive 10ml of normal saline(placebo).Depending on the group,the study solution will be administered to the patients intravenously five minutes before giving spinal block.Intra operatively spinal anaesthesia will be given and haemodynamic parameters such as heart rate,systolic and diastolic blood pressure,mean arterial pressure will be recorded.Incidence of hypotension,volume of intravenous fluid used,requirement of vasopressors like Ephedrine,Phenylephrine and need of Atropine will be noted. |