Comparing effectiveness of two injections in preventing fall in BP after spinal anaesthesia in Caesarean section

Not Applicable

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2025/05/086787
• Lead Sponsor: Sushma

Brief Summary

This study is a prospective, randomised, double blinded, comparative trial, to compare the efficacy of prophylactic intravenous administration of two serotonin receptor antagonists i.e., ondansetron 4 mg and granisetron 3 mg in preventing spinal induced hypotension and bradycardia in parturients undergoing elective lower segment caesarean section. The study population will be allocated in two groups with 50 parturients in each group, and one of the study drug will be given 5 minutes before spinal anaesthesia and hemodynamic parameters such as blood pressure, heart rate and mean arterial pressure will b monitored intraoperatively.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-13
• Study Start: 2025-05-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Parturients belonging to ASA grade 1 and 2 with more than 36 weeks gestation undergoing elective LSCS for a singleton pregnancy with Height 150.

Exclusion Criteria

• Patient refusal Parturients with spinal deformity Parturients with medical and obstretric complications like anemia, cardiac disease, gestational hypertension, gestational diabetes, shock, liver disorders, septicemia and hypertension.
• Known hypersensitivity to local anaesthetics and study drugs.
• Subjects having any absolute or relative contraindications for spinal anaesthesia like raised intracranial pressure, severe hypovolemia, bleeding diathesis and local infection.
• Parturients with BMI more than 30 On drugs like selective serotonin reuptake inhibitors and migraine medications.
• Intraoperative blood loss more than1 litre.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of hemodynamic parameters like systolic blood pressure and heart rate	2,4,6,8,10,15,20,25,30,35,40,50,60,70,80,90 minutes and till 3 hours postoperative period

Secondary Outcome Measures

Name	Time	Method
To assess total requirement of intravenous ephedrine to treat hypotension and to assess intravenous atropine to treat bradycardia	to assess incidence of nausea vomiting and intra operative and post operative shivering

Trial Locations

Locations (1)

Mysore medical college and research institute; 🇮🇳 Mysore, KARNATAKA, India

Mysore medical college and research institute

🇮🇳Mysore, KARNATAKA, India

Dr Sushma

Principal investigator

8951994799

sushmamaroorkar@gmail.com