Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-01-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Lower Extremity Chronic Venous Ulcers Varicose Veins Leg Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tramadol group

Intravenous Tramadol

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

Intravenous tramadol

Magnesium sulphate group

Intravenous Magnesium Sulphate

Group Type EXPERIMENTAL

Magnesium sulphate

Intervention Type DRUG

Intravenous magnesium sulphate

Control group

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Normal saline

Interventions

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Tramadol

Intravenous tramadol

Intervention Type DRUG

Magnesium sulphate

Intravenous magnesium sulphate

Intervention Type DRUG

Saline

Normal saline

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No