To compare the effect of two different doses of drug known to prevent fall in blood pressure(ondansetron) in caesarean delivery by calculating the dose of injection of blood pressure raising medicine(ephedrine) required to control fall in blood pressure.

Phase 3

Not yet recruiting

• Conditions: Encounter for cesarean delivery without indication, (2) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,

• Registration Number: CTRI/2023/08/057012
• Lead Sponsor: Department of Anaesthesiology, SMS Medical College and attached Hospitals, Jaipur

Brief Summary

The aim of this study is to compare the efficacy of two different dose of intravenous ondansetron in preventing the hypotension after spinal anaesthesia by calculating the total dose of ephedrine required to control hypotension in patients undergoing elective caesarean section. In this study two different doses of intravenous ondansetron 4mg and 8mg will be given 5 minutes before spinal anaesthesia . Total dose of ephedrine required to control hypotension will be calculated in both groups. This will help us to know the effective dose of ondansetron to prevent hypotension in LSCS cases under spinal anaesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-09
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

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

Inclusion Criteria

• 1. Patients undergoing elective caesarean section.
• 2. Age between 18-35 years.
• 3. Patients belonging to American Society Of Anaesthesiologist(ASA) grade II.
• 4. Patients consenting to participate.

Exclusion Criteria

• 1)History of pre eclampsia and eclampsia.
• 2)Obesity 3)Patients with allergy to drugs used in the study.
• 4)Patients with contraindication to neuraxial anaesthesia.
• 5)Patients with history of drug abuse or addictions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)To determine the difference in total dose of ephedrine required to control hypotension between two different doses of intravenous ondansetron in parturients undergoing elective lower segment caesarean section .	Baseline | 00 minutes(after spinal) | 01 minutes | 02 minutes | 03 minutes | 05 minutes | 10 minutes | 15 minutes | 20 minutes | 25 minutes | 30 minutes | 40 minutes | 50 minutes | 60 minutes
2)To determine the difference in proportion of hypotension between two different doses of intravenous ondansetron in parturients undergoing elective lower segment caesarean section.	Baseline | 00 minutes(after spinal) | 01 minutes | 02 minutes | 03 minutes | 05 minutes | 10 minutes | 15 minutes | 20 minutes | 25 minutes | 30 minutes | 40 minutes | 50 minutes | 60 minutes

Secondary Outcome Measures

Name	Time	Method
To determine side effects between both groups -Nausea, Vomiting, shivering, bradycardia	The application of spinal anaesthesia till completion of surgery.

Trial Locations

Locations (1)

Pandit Deen Dayal Upadhyaya Hospital,Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Pandit Deen Dayal Upadhyaya Hospital,Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Harpreet Kaur

Principal investigator

9899785993

rupihar@gmail.com