Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering

Phase 4

Not yet recruiting

• Conditions: Lower Extremity Chronic Venous Ulcers; Varicose Veins Leg; Hernia
• Interventions: Drug: Tramadol; Drug: Magnesium sulphate; Other: Saline

• Registration Number: NCT06612996
• Lead Sponsor: Al-Azhar University

Brief Summary

The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Study Start: 2024-10-10
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.

Exclusion Criteria

• history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever >38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol group	Tramadol	Intravenous Tramadol
Magnesium sulphate group	Magnesium sulphate	Intravenous Magnesium Sulphate
Control group	Saline	Saline

Primary Outcome Measures

Name	Time	Method
Shivering score	90 minutes postoperatively	Shivering score