A study to determine the effect of ondansetron in prevention of hypotension in caesarean delivery under spinal anaesthesia

Effect of prophylactic intravenous ondansetron in the prevention of spinal anaesthesia induced hypotension during caesarean delivery-A prospective randomized double blinded study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037517

Enrollment

150

Registered

2021-10-25

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: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: ONDANSETRON: ONDANSETRON 4mg,intravenous 5 minutes before starting the study ONDANSETRON 8mg,intravenous 5 minutes before starting the study Control Intervention1: PLACEBO: Normal sal

Eligibility

Inclusion criteria

Inclusion criteria: 1)Parturients aged 18 to 45 years 2)American Society Of Anesthesiologits physical status less than III 3)Singleton term pregnancy(more than 37 weeks gestation) 4)Scheduled for elective caesarean delivery under regional anaesthesia

Exclusion criteria

Exclusion criteria: 1)Patient refusal 2)Hypersensitivity to Ondansetron 3)Contraindication for spinal anesthesia 4)Hypertensive disorders and diabetes with pregnancy 5)History of nausea,vomiting during the 24 hours before induction of anaesthesia 6)Multiple gestation 7)Patient receiving selective serotonin reuptake inhibitor

Design outcomes

Primary

Measure	Time frame
To estimate the magnitude of the effect of Ondansetron versus placebo in reducing the incidence of spinal anaesthesia induced hypotension during caesarean deliveryTimepoint: 1 Year	—

Secondary

Measure	Time frame
The requirement of phenylephrine,ephedrine and atropine. Timepoint: 1 Year	—

Countries

India

Contacts

Public ContactDr Mahesh Vakamudi

Sri Ramachandra Institute Of Higher Education And Research

vakamudi@gmail.com9840022626

Outcome results

None listed

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