A clinical trial to compare the effect of ondansetron in fixed dose versus according to body weight dose to prevent shivering following spinal anaesthesia for caesarean deliveries

Comparison of weight adjusted dose versus fixed dose ondansetron in preventing shivering following spinal anaesthesia for caesarean deliveries

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045156

Enrollment

190

Registered

2022-09-01

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: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Weight adjusted ondansetron 0.1mg/kg is given before spinal anaesthesia in elective caesarean section: Weight adjusted ondansetron 0.1mg/kg is given before spinal anaesthesia in caesare

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists Physical status 2 2. Patients who have given informed and written consent 3. Patients scheduled for elective caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. American Society of Anaesthesiologists Physical status 3 or 4 2. Patients unwilling to participate in the study 3. Preoperative use of ondansetron and tramadol 4. Presence of shivering prior to administration of spinal anaesthesia 5. Allergy or intolerance to ondansetron 6. With initial body temperature more than 38 degree celsius or less than 36.5 degree celsius 7. Presence of fetal distress or fetal abnormalities 8. Pre-existing or pregnancy induced hypertension, gestational diabetes mellitus, thyroid disorders 9. Patients with cardiac diseases, liver dysfunction and renal dysfunction

Design outcomes

Primary

Measure	Time frame
To compare the incidence of shivering following spinal anaesthesia when a weight adjusted dose versus fixed dose of ondansetron is used during caesarean delivery.Timepoint: After giving spinal anaesthesia every 5 mins till patient is shifted to PACU	—

Secondary

Measure	Time frame
To compare the severity of shivering between the two groupsTimepoint: After giving spinal anaesthesia every 5 mins till patient is shifted to PACU	—

Countries

India

Contacts

Public ContactDr Rajib Hazarika

Gauhati medical college and hospital

rajibhazarika8@gmail.com9864063140

Outcome results

None listed

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