Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section

Assiut University

Status and phase: Completed; Phase 4

Conditions: Hypotension

Treatments: Drug: Normal saline; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02913768

Ondansetron for CS

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

Ondansetron

Active Comparator group

Description:

Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia

Treatment:

Drug: Ondansetron

control

Placebo Comparator group

Description:

Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia

Treatment:

Drug: Normal saline