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administration of Ondansetron before spinal anaesthesia for prevention of hypotension in elective caesarean section.

Efficacy of prophylactic ondansetron on prevention of spinal anaesthesia induced hypotension during caesarian delivery; a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031305
Enrollment
64
Registered
2021-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: ondansetron: inj. Ondansetron 8 mg iv (4 ml +6ml NS), 5 min before Spinal Injection to prevent hypotension by Bezold jarisch reflex. Control Intervention1: placebo: receives normal sali

Sponsors

Vijayanagar institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Primiparous and multiparous parturient women with a single foetus posted for Elective caesarean section 2)37â??42 weeks of gestation 3)ASA grade II 4)Normal foetal profile

Exclusion criteria

Exclusion criteria: 1)Contraindication for or refusal of spinal anaesthesia 2)Hypertension (SBP >140 mm Hg or DBP >90 mm Hg), Chronic or gestational hypertension or preeclampsia 3)Cardiovascular and/or cerebrovascular diseases 4)Diabetes mellitus 5)Administration of 5-hydroxytryptamine (5-HT3) reuptake inhibitors or drugs for the treatment of migraines 6)Treatment with antiemetics (including 5 HT3 blockers) within 72 h of surgery 7)Hypersensitivity to ondansetron, fentanyl, or bupivacaine 8)Obesity

Design outcomes

Primary

MeasureTime frame
Incidence of hypotensionTimepoint: after spinal anaesthesia throughout the procedure.—

Secondary

MeasureTime frame
1)Need of vasopressors 2)intraoperative nausea and vomiting (INOV) 3)neonatal outcomes in terms of APGAR score Timepoint: after spinal anaesthesia throughout the procedure—

Countries

India

Contacts

Public ContactDr Parimala

VIMS Ballari

pamraichur@gmail.com8884980978

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026