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A comparative study of Tramadol, Ondansetron and a combination of Tramadol and Ondansetron in prevention of shivering after Spinal Anaesthesia during elective surgery.

A comparative study of Tramadol, Ondansetron and a combination of Tramadol and Ondansetron in prevention of intraoperative shivering in patients undergoing elective surgery under Spinal Anaesthesia - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/062037
Enrollment
81
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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: A comparative study of Tramadol, Ondansetron and a combination of Tramadol and Odansetron in prevention of intraoperative shivering in patients undergoing elective surgery under Spinal

Sponsors

RAJDEEP DUTTA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II undergoing elective infraumbilical surgery under Spinal Anaesthesia

Exclusion criteria

Exclusion criteria: Patients having contraindications for Spinal Anaesthesia like lack of consent, raised intracranial tension, infection at local site, severe aortic stenosis, coagulopathy, cardiovascular instability. Patients with known allergy to study drugs. Patients with BMI more than 30 kg per meter square. Patients with ASA status III or more. Patients having major cardiovascular, respiratory, renal, hepatic, metabolic, neurological or endocrine disorders. Patients requiring General Anaesthesia. Patients having history of convulsions. An initilal or core temperature of more than 37.5 degree C or less than 35.5 degree C. Patients receiving intra operative blood transfusion. Patients receiving any other anti emetic. Patients receiving Tramadol or Ondansetron pre operatively. Patients having arrhythmia or prolonged QTc.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative shiveringTimepoint: 120 MINUTES

Secondary

MeasureTime frame
Severity of intraoperative shivering & incidence of other side effects like nausea, vomiting etc.Timepoint: 120 MINUTES

Countries

India

Contacts

Public ContactDr. SUDESHNA 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