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Comparing Tramadol, Ketamine, and Ondansentron in the prevention of post-spinal anaesthesia shivering.

A comparative study of prophylactic Tramadol, Ketamine and Ondansetron in the prevention of intraoperative shivering in patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075777
Enrollment
93
Registered
2024-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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: Tramadol: Tramadol 0.5mg/kg IV to be given 5 minutes before spinal anaesthesia. Intervention2: Ketamine: Ketamine 0.2 mg/kg IV to be given 5 minutes before spinal anaesthesia. Intervent

Sponsors

M Thangadurai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of age 18-45 years. 2. Either sex. 3. ASA physical status I & II undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients having contraindications for spinal anaesthesia like lack of consent, raised intracranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability. 2. Patients with known allergy to study drugs. 3. Patients with BMI > 30 kg/m2. 4. Patients ASA physical status III or more. 5. Patients having major cardiovascular, respiratory, renal, hepatic, metabolic, neurological or endocrine diseases. 6. Patients with failed spinal anaesthesia. 7. Patients requiring general anaesthesia. 8. Patients having history of convulsion. 9. An initial or core temperature more than 37.5 C or less than 35.5 C. 10. Patients receiving intraoperative blood transfusion. 11. Patients receiving any other anti-emetic. 12. Patients receiving tramadol, ketamine or ondansetron in the pre-operative period. 13. Patients having arrhythmia or prolonged QTc. 14. Patients with history of opiod/alcohol /substance abuse.

Design outcomes

Primary

MeasureTime frame
Incidence of shiveringTimepoint: 12 months

Secondary

MeasureTime frame
1. Severity of intraoperative shivering. 2. incidence of other side effects like nausea, vomiting, sedation.Timepoint: 12 months.

Countries

India

Contacts

Public ContactSudeshna Bhar Kundu

Calcutta National Medical College and Hospital

sudeshna04cmc@yahoo.co.in8777725424

Outcome results

None listed

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