A study to evaluate the effect of ondansetron on blood pressure in pregnant females undergoing caesarean delivery under spinal anaesthesia

Not Applicable

Completed

• Conditions: Health Condition 1: null- Pregnancy

• Registration Number: CTRI/2018/03/012692
• Lead Sponsor: Department of Anaesthesiology and Critical Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-27
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

full term parturients, belonging to American Society of Anesthesiologists (ASA) physical status I and II, having singleton pregnancy undergoing caesarean section with pfannenstiel incision under spinal anaesthesia.

Exclusion Criteria

Patients having:

1. Any contraindication for spinal anaesthesia (patient refusal, unstable haemodynamics and coagulation abnormality).

2. Significant obstetric diseases such as pregnancy induced hypertension (PIH) or preeclampsia.

3. Known risk factors for post partum haemorrhage (PPH).

4. History of hypersensitivity to ondansetron or local anaesthetic agent.

5. Cardiovascular or cerebrovascular disease.

6. Patients receiving selective serotonin reuptake inhibitors (SSRI) or serotonin related migraine medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate and compare the effect of three different doses of prophylactic intravenous ondansetron (4, 6 and 8 mg) with placebo on haemodynamic parameters (HR, SBP, DBP, MAP, SPo2) in parturients undergoing caesarean section under spinal anaesthesia.Timepoint: Hypotension, defined as fall in systolic blood pressure (SBP) more than 20 % of the baseline, and Bradycardia, defined as HR less than 50.bpm

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of different doses of ondansetron compared with placebo on need of ephedrine ,atropine and adverse effects (Nausea, Vomiting, Shivering)Timepoint: Hypotension, defined as fall in systolic blood pressure (SBP) more than 20 % of the baseline, was treated with boluses of 6 mg intravenous ephedrine. Bradycardia, defined as HR less than 50 bpm, was treated with boluses of 0.6 mg intravenous atropine.