Clinical trial NCT04249804: the Use of Magnesium Sulfate for Prevention of Postspinal Shivering
Official title: Intravenous Infusion Versus Intrathecal Injection of Magnesium Sulfate for Prevention of Postspinal Shivering During Lower Limb Fracture Surgery. A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prevention of Postspinal Shivering
Keywords: Magnesium Sulfate - postspinal shivering -intrathecal - infusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly allocated to Groups (\[T\], Intrathecal MgSo4 and \[M\], IV infusion MgSo4 groups) on the basis of computer-generated random numbers. Patients belonging to Group T (n = 45) will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine \[131\],while those belonging to Group M (group, n = 45) 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.

Axillary temperature and grades of shivering will be noted every 10 min by the same anesthesiologist who performed the spinal anesthesia using Crossley and Mahajan scale,\[8\] If grade III, IV shivering persisted for \>10 min pethidine 25 mg IV will be administered as a rescue drug and number of patients required rescue drug will be recorded.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of postspinal shivering
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: anesthesia department at Cairo University
state: Elmanial
Study officials:
References:
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