Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering

Al-Azhar University

Status and phase: Not yet enrolling; Phase 4

Conditions: Lower Extremity Chronic Venous Ulcers; Varicose Veins Leg; Hernia

Treatments: Drug: Tramadol; Drug: Magnesium sulphate; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06612996

AZAST/19/14-May-2024

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Tramadol group

Experimental group

Description:

Intravenous Tramadol

Treatment:

Drug: Tramadol

Magnesium sulphate group

Experimental group

Description:

Intravenous Magnesium Sulphate

Treatment:

Drug: Magnesium sulphate

Control group

Placebo Comparator group

Description:

Saline

Treatment:

Other: Saline