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A clinical trial to study the effects of prophylactic Ondansetron and Palonosetron for prevention of post spinal shivering.

Comparison of efficacy of Ondansetron and Palonosetron for prevention of post spinal shivering during lower limb surgeries.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035714
Enrollment
210
Registered
2021-08-17
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: V00-Y99- External causes of morbidity

Interventions

Intervention1: Comparison of efficacy of Ondansetron and Palonosetron for prevention of post-spinal shivering in lower limb sugeries.: Patients of group A will be given Ondansetron 8mg before spinal a

Sponsors

Dayanand Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex ,aged 18-60 years belonging to ASA I â??III, after written informed consent.

Exclusion criteria

Exclusion criteria: 1. Failed spinal anaesthesia. 2. Prolonged surgical time leading to supplement/ conversion to general anaesthesia. 3. Any contraindication to spinal anaesthesia. 4. Patient needing blood transfusion. 5. Parkinsons disease. 6. Patient with known endocrine disease. 7. Diabetic autonomic neuropathy. 8. Patients having any dysarryrthmias on pre-operative ECG. 9. Known hypersensitivity to any of the drugs used in the study.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of prophylactic Ondansetron and Palonosetron in reducing the incidence and severity of post spinal shivering.Timepoint: The hemodynamic parameters, core and peripheral body temperature will be monitored perioperatively and in PACU at 30 minutes interval. Sensory and motor blockade will be assessed. Any episode of shivering will be recorded, graded as per Wrench.Grade3,4 will be given rescue drug Tramadol 50mg IVbolus.

Secondary

MeasureTime frame
To observe hemodynamic changes and side effects ,if anyTimepoint: Hemodynamic parameters will be monitored perioperatively and in PACU for 6hours.

Countries

India

Contacts

Public ContactDr Deepshikha

Dayanand Medical College and Hospital

ndeepshikha14@yahoo.com8847431601

Outcome results

None listed

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