A Prospective Randomised double blinded study to compare the efficacy of prophylactic intravenous administration of Ondansetron 4 mg and granisetron 3mg for attenuation of spinal induced hypotension in parturients undergoing elective lower segment Caesarean section
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Comparison of hemodynamic parameters like systolic blood pressure and heart rate
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
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.
Outcomes
Primary Outcomes
Comparison of hemodynamic parameters like systolic blood pressure and heart rate
Time Frame: 2,4,6,8,10,15,20,25,30,35,40,50,60,70,80,90 minutes and till 3 hours postoperative period
Secondary Outcomes
- 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)