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A study to evaluate the effect of ondansetron on blood pressure in pregnant females undergoing caesarean delivery under spinal anaesthesia

A study to evaluate the effect of ondansetron on spinal induced hypotension in parturients undergoing caesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012692
Enrollment
240
Registered
2018-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: null- Pregnancy

Interventions

Intervention1: Ondansetron drug (4mg,6mg,8mg): Ondansetron (selective serotonin 5-HT3 receptor antagonist) was used in three different doses (4 mg, 6 mg and 8 mg) diluted with 0.9% saline to total vol

Sponsors

Department of Anaesthesiology and Critical Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: full term parturients, belonging to American Society of Anesthesiologists (ASA) physical status I and II, having singleton pregnancy undergoing caesarean section with pfannenstiel incision under spinal anaesthesia.

Exclusion criteria

Exclusion criteria: Patients having: 1. Any contraindication for spinal anaesthesia (patient refusal, unstable haemodynamics and coagulation abnormality). 2. Significant obstetric diseases such as pregnancy induced hypertension (PIH) or preeclampsia. 3. Known risk factors for post partum haemorrhage (PPH). 4. History of hypersensitivity to ondansetron or local anaesthetic agent. 5. Cardiovascular or cerebrovascular disease. 6. Patients receiving selective serotonin reuptake inhibitors (SSRI) or serotonin related migraine medications.

Design outcomes

Primary

MeasureTime frame
Evaluate and compare the effect of three different doses of prophylactic intravenous ondansetron (4, 6 and 8 mg) with placebo on haemodynamic parameters (HR, SBP, DBP, MAP, SPo2) in parturients undergoing caesarean section under spinal anaesthesia.Timepoint: Hypotension, defined as fall in systolic blood pressure (SBP) more than 20 % of the baseline, and Bradycardia, defined as HR less than 50.bpm—

Secondary

MeasureTime frame
To evaluate the effect of different doses of ondansetron compared with placebo on need of ephedrine ,atropine and adverse effects (Nausea, Vomiting, Shivering)Timepoint: Hypotension, defined as fall in systolic blood pressure (SBP) more than 20 % of the baseline, was treated with boluses of 6 mg intravenous ephedrine. Bradycardia, defined as HR less than 50 bpm, was treated with boluses of 0.6 mg intravenous atropine.—

Countries

India

Contacts

Public ContactDr Sumedha Vashishth

Pt B D Sharma, PGIMS, UHS, Rohtak

summivashishth@gmail.com8221986262

Outcome results

None listed

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