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Effect of ondansetron in decreasing occurrence of low blood pressure during caesarean operation in pregnant women with high blood pressure

Effect of preoperative intravenous ondansetron in attenuating spinal anaesthesia-induced hypotension in patients with hypertensive disorders of pregnancy undergoing Caesarean delivery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017489
Enrollment
100
Registered
2019-02-06
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: O164- Unspecified maternal hypertension,complicating childbirth

Interventions

Intervention1: Ondansetron: Ondansetron 4 mg diluted in 10 ml saline intravenously over 2 min Control Intervention1: Saline: normal saline 10 ml administered intravenously over 2 min

Sponsors

Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists physical status II and III women with hypertensive disorders of pregnancy 2. Term singleton pregnancy 3. Scheduled for elective Caesarean delivery under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. Eclampsia, HELLP syndrome, diabetes mellitus, valvular heart or cerebrovascular disease 2. Onset of labour, foetal abnormality or distress 3. Allergy to study medication or patients receiving 5-hydroxytryptamine reuptake inhibitors 5. Weight less than 50 kg or more than 100 kg 6. Height less than 140 cm or more than 170 cm 7. Coagulopathy, thrombocytopenia 8. Contraindication to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of ondansetron administration on the incidence and severity of spinal anaesthesia induced hypotension in patients with hypertensive disorders of pregnancy undergoing elective Caesarean deliveryTimepoint: Intraoperative period—

Secondary

MeasureTime frame
1. To evaluate the effect of ondansetron administration on the incidence of maternal bradycardia, nausea, vomiting and vasopressor consumption in above patients. 2. To evaluate the effect of ondansetron administration on neonatal outcome by Apgar scores and umbilical cord blood gas analysis. Timepoint: Intraoperative period—

Countries

India

Contacts

Public ContactSmita Prakash

Vardhman Mahavir Medical College and Safdarjung Hospital

drsunilprakash@gmail.com9810347125

Outcome results

None listed

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