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Effect of Ondansetron on maternal blood pressure and neonatal parameters when given before spinal anaesthesia during caesarean section

Effect of Ondansetron given preoperatively on maternal hypotension and neonatal parameter in patients undergoing elective caeserean section under spinal anaesthesia - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064356
Enrollment
200
Registered
2024-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: Intravenous Ondansetron before spinal anesthesia: 0.1mg/kg dose of Ondansetron diluted with 0.9% Normal saline (total volume 10ml) is given Intravenously (single dose) 10min prior to sp

Sponsors

Rajendra Institute Of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient consent Pregnant females between 18 to 45 years of age posted for elective caeserean section in Rajendra Institute of Medical Sciences

Exclusion criteria

Exclusion criteria: Emesis gravidarum Preeclampsia Morbid obesity Contraindications to spinal anesthesia, allergy or intolerance to local anaesthetic agents or other agents used for the study. Presence of co-morbidities like severe anaemia, uncontrolled diabetes mellitus, asthma, uncontrolled hypertension, severe cardiac disease Patient’s belonging to ASA III and above

Design outcomes

Primary

MeasureTime frame
1.Changes in Systolic blood pressure 2. Changes in diastolic blood pressure 3.Changes in mean arterial pressure 4.Changes in Heart RateTimepoint: 1.From time of induction, every 2 minutes till 20minutes and thereafter every 5minutes till 50minutes. 2.From time of induction, every 2 minutes till 20minutes and thereafter every 5minutes till 50 minutes. 3. From time of induction, every 2 minutes till 20minutes and thereafter every 5minutes till 50minutes. 4.From time of induction, every 2 minutes till 20minutes and thereafter every 5minutes till 50minutes.

Secondary

MeasureTime frame
1.Fetal umblical artery pH,lactate,bicarbonate, sodium, potassium, chloride and calcium levels by arterial blood gas analysis. 2. APGAR scoreTimepoint: 1. Immediately after delivery (ideally within 3 minutes) 2. At 1 minute, 3 minute, 5minute and 10minutes post delivery

Countries

India

Contacts

Public ContactDr Ladhu Lakra

Rajendra Institute Of Medical Sciences

wasu077@gmail.com8797770602

Outcome results

None listed

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