CompletedPhase 3Phase 4ACTRN12613000036718

the effect of ondansetron on hypotension due to spinal anesthesia for caesarean section.

spinal-induced hypotension reduction with ondansetron in parturients undergoing caesarean section: A double-blind randomised, controlled study.


Sponsor

Tunisian Military Hospital

Enrollment

80 participants

Start Date

Feb 5, 2013

Study Type

Interventional

Conditions

Summary

spinal-induced hypotension results primarily from decreased vascular resistance secondary to a relative parasympathetic dominance, increased baroreceptor activity, or induction of the Bezold Jarisch Reflex (BJR). several animal studies suggest that 5-HT (serotonin) may be an important factor associated inducing the BJR. We hypothesized that spinal-induced hypotension and bradycardia could be minimized with the use of intravenous ondansetron, a 5-HT3 receptor antagonist, in obstetric patients undergoing caesarean section.


Eligibility

Sex: FemalesMin Age: 20 YearssMax Age: 45 Yearss

Inclusion Criteria1

  • parturients ,who were ASA physical status I, undergoing an elective caesarean section

Exclusion Criteria4

  • Parturients 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 and parturients receiving selective serotonin reuptake inhibitors

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Interventions

4 mg ondansetron (4 milliliters) given intravenously, 5 minutes before spinal anesthesia (using 10 mg hyperbaric bupivacaine 0.5% plus 2.5 microgramm sufentanil)

4 mg ondansetron (4 milliliters) given intravenously, 5 minutes before spinal anesthesia (using 10 mg hyperbaric bupivacaine 0.5% plus 2.5 microgramm sufentanil)


Locations(1)

TUNIS, Tunisia

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ACTRN12613000036718