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

Phase 4
Completed
Conditions
Hypotension
Interventions
Drug: Normal saline
Drug: Ondansetron
Registration Number
NCT02913768
Lead Sponsor
Assiut University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
160
Inclusion Criteria
  • Undergoing an elective lower segment caesarean section.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
controlNormal salineNormal Saline 10 mL over 1 min, 5 min before spinal anaesthesia
OndansetronOndansetronIntravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia
Primary Outcome Measures
NameTimeMethod
Hypotensionintraoperative

Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg

Secondary Outcome Measures
NameTimeMethod
Bradycardiaintraoperative

HR \<50 beats/min

Trial Locations

Locations (1)

Assiut University hospital

🇪🇬

Assiut, Asyut Governorate, Egypt

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