the Use of Magnesium Sulfate for Prevention of Postspinal Shivering

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Prevention of Postspinal Shivering

Treatments: Drug: Magnesium Sulfate 1000 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04249804

MS-261-2019

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Intrathecal Mg group

Experimental group

Description:

45 patients will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine

Treatment:

Drug: Magnesium Sulfate 1000 MG

IV Mg infusion group

Experimental group

Description:

45 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

Treatment:

Drug: Magnesium Sulfate 1000 MG

control

No Intervention group

Description:

0.5% heavy bupivacaine in the spinal with no additives