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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000036718

Enrollment

Registered

2013-01-14

Start date

2013-02-05

Completion date

2013-10-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Outcome results