Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Ondansetron
- Conditions
- Hypotension
- Sponsor
- Assiut University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Hypotension
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is associated with hypotension and bradycardia, which may be deleterious to both parturient and baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following subarachnoid block in parturients undergoing elective caesarean section.
Investigators
Mostafa Samy Abbas
lecturer of anesthesia and ICU, Assiut University,Assiut, Egypt
Assiut University
Eligibility Criteria
Inclusion Criteria
- •Undergoing an elective lower segment caesarean section.
Exclusion Criteria
- •Patients with contraindications to subarachnoid block (patient refusal, unstable haemodynamics, coagulation abnormality),
- •History of hypersensitivity to ondansetron or local anaesthetic agents,
- •Hypertensive disorders of pregnancy,
- •Cardiovascular insufficiency,
- •Receiving selective serotonin reuptake inhibitors or migraine medications.
Arms & Interventions
Ondansetron
Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia
Intervention: Ondansetron
control
Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia
Intervention: Normal saline
Outcomes
Primary Outcomes
Hypotension
Time Frame: intraoperative
Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg
Secondary Outcomes
- Bradycardia(intraoperative)