A study to determine the effect of ondansetron in prevention of hypotension in caesarean delivery under spinal anaesthesia

Phase 3

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2021/10/037517
• Lead Sponsor: Dr Monisha Ravichandran

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
The requirement of phenylephrine,ephedrine and atropine.

Trial Locations

Locations (1)

Sri Ramachandra Institute Of Higher Education And Research; 🇮🇳 Chennai, TAMIL NADU, India

Sri Ramachandra Institute Of Higher Education And Research

🇮🇳Chennai, TAMIL NADU, India

Dr Monisha Ravichandran

Principal investigator

9442461287

m2320012@sriramachandra.edu.in