MedPath

the Use of Magnesium Sulfate for Prevention of Postspinal Shivering

Phase 4
Completed
Conditions
Prevention of Postspinal Shivering
Interventions
Drug: Magnesium Sulfate 1000 MG
Registration Number
NCT04249804
Lead Sponsor
Cairo University
Brief Summary

Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which plays a significant role in temperature regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below the block level) to the peripheral tissues. These two effects predispose patients to hypothermia and shivering. The median incidence of shivering related to regional anesthesia observed in a review of 21 studies is 64.4%. Shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid these intraoperative and postoperative shivering-induced increases in hemodynamic and metabolic demands is to prevent shivering in the first place. Although magnesium is among several pharmacological agents used for the treatment of shivering, its effects on prevention of shivering during central neuraxial blockade have not been evaluated to date. Henceforth, the aim of this study was to evaluate the effect of magnesiume on shivering during spinal anesthesia.

Aim:

to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention of post spinal shivering in adult patients undergoing elective lower limb orthopedic surgeries.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria
  • Age between 20-45 years old
  • Both genders
  • ASA I, II
Exclusion Criteria
  • Patients with hemodynamic instability
  • cardiopulmonary
  • renal , liver disease
  • hypo or hyperthyroidism
  • cerebrovascular insufficiency
  • coagulation defects
  • those with psychiatric disorder
  • patients receiving vasoactive drugs or beta blockers
  • BMI > 35
  • allergic to study drug
  • height <160 cm or >190 cm
  • basal body temperature >38°C or <36°C
  • those who received blood transfusion or >2000 mL fluid intra-operatively
  • surgery duration > 3 hours

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IV Mg infusion groupMagnesium Sulfate 1000 MG45 patients will receive IV magnesium sulfate 50 mg/kg in 100 mL isotonic saline over 20 min as a bolus then 2 mg/kg/h infusion using a separate infusion set after administering spinal anesthesia
Intrathecal Mg groupMagnesium Sulfate 1000 MG45 patients will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine
Primary Outcome Measures
NameTimeMethod
incidence of postspinal shiveringup to 5 months

the efficacy of the use of MgSo4 IV infusion versus intrathecal injection in decreasing the incidence of postspinal shivering using Crossley and Mahajan scale which is 0, no shivering; 1, piloerection or peripheral vasoconstriction (cyanosis) but no visible shivering; 2, muscular activity in only one muscle group; 3, muscular activity in more than one muscle group but not generalized shivering; and 4, shivering involving the whole body

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

anesthesia department at Cairo University

🇪🇬

Cairo, Elmanial, Egypt

© Copyright 2025. All Rights Reserved by MedPath