Comparison of MgSO4 Versus Meperidine for Prevention of Shivering During Spinal Anesthesia
Condition: Shivering
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a double-blind randomized interventional study of 100 patients divided into two
      groups. Group M received MgSO4 30 mg/kg, and group P received meperidine 0.5 mg/kg
      intravenously in 100 ml of 0.9% NaCl before undergoing spinal anesthesia. Participants were
      non-pregnant patients between 18-65 years of age, belonging to the American Society of
      Anesthesiologist physical status I or II. Shivering was regarded as significant if it
      occurred at grade 3 or 4. Data of patient characteristics, shivering degree, tympanic
      membrane temperature, vital sign, and side effects were recorded.
    

Detailed description: 
      Study Design This was double-blinded randomized clinical trial that was conducted in Dr.
      Cipto Mangunkusumo National General Hospital in February - June 2021 after due permission
      from Ethics Committee of the Faculty of Medicine University of Indonesia - Cipto Mangunkusumo
      Hospital (No. KET-1510/UN2.F1/ETIK/PPM.00.02/2020). Patients were randomly devided into two
      groups to recieved MgSO4 30 mg/kg (group M) and meperidine 0.5 mg/kg (group P). Drugs will be
      prepared and delivered by another anesthesiologist outside of the research team.

      Subjects Following patient informed consent, 100 patients aged 18-65 years old, with American
      Society of Anesthesiologist (ASA) physical status I or II who underwent spinal anesthesia.
      The following groups of patients were excluded from the study: patients with a history of
      allergy to the drugs used in the study, pregnant patients, neuromuscular disease,
      hyperthyroid, severe cardiopulmonary diseases, liver and/or renal disorders, used drugs that
      could interact with MgSO4 such as nifedipine, and preoperative body temperature less than
      36oC or more than 37.5oC. Patients were dropped out if: any complications such as systemic
      allergic reaction, anaphylaxis, cardiac arrest was occured, failure of spinal anesthesia,
      respinal, surgery duration less than 30 minutes, and conversion to general anesthesia during
      evaluation.

      Interventions and Outcomes After randomization, subjects would be given drugs according to
      their randomization group. MgSO4 30 mg/kg and meperidine 0.5 mg/kg were dissolved in 100 ml
      NaCl 0.9%, and labeled as "research drug" for blinding. Drugs were given in 10 minutes while
      patients were monitored for side effects such as hypotension, bradycardia, nausea, vomiting,
      itch, allergy, drowsiness, and respiratory depression. If hypotension occurs or blood
      pressure decreases >20% from baseline, patients will be treated with a crystalloid solution
      and intravenous ephedrine 5-10 mg.

      Afterwards, patients were given 10 ml/kg crystalloid with room temperature 22oC - 23oC for 10
      minutes before spinal anesthesia. Spinal anesthesia was performed at the lumbar vertebrae 3-4
      or 4-5 interspaces, with 15 mg hyperbaric bupivacaine and fentanyl 25 mcg. Room temperature
      was maintained between 19oC - 24oC. Patients were covered with one layer of blanket, which
      covered the chest and upper arm, and other areas outside the operating area. Patients were
      given fluid maintenance of 2 ml/kg/hour crystalloid and oxygen supplementation 2-3 l/minute
      by nasal cannula. Patient ini this study also were managed in the state of Ramsay sedation
      scale 2 (co-operative, oriented, and tranquil) or 3 (appears asleep, but responds to verbal
      command), so some patient were given midazolam intravenously to maintain the condition.

      The incidence of shivering, mean arterial pressure, heart rate, respiratory rate, and
      tympanic membrane temperature were observed every five minutes during the first 15 minutes
      and every 15 minutes within the next 120 minutes. The degree of shivering was measured with
      Crossley and Mahajan scale which is 0 = No shivering, 1 = piloerection or peripheral
      vasoconstriction, 2 = muscular activity in only 1 muscle group, 3 = muscular activity in more
      than 1 muscle group but not generalized, and 4 = intens shivering involving the whole body,
      except in the muscle affected by spinal block.6 Drugs were considered effective if they could
      prevent the incidence of 3rd or 4th degree shivering. Meperidine 25 mg intravenously was
      given if 3rd or 4th degree shivering occurred. Nausea and vomiting was treated by IV
      metoclopramide 10 mg. Postoperatively, all patients were transferred to recovery room and
      monitored for one hour until discharge.

      Statistical Analysis All statistical analyses were performed using SPSS (Statistical Package
      for Social Sciences) version 20.0. Chi-square test or Fisher's exact test were used to
      compare the difference of proportion in shivering between the two groups. For numerical data,
      T-test and Mann-Whitney test were used. P<0.05 was considered statistically significant.
    

Intervention name(s): Magnesium sulfate; Meperidine
Intervention type(s): Drug; Drug
Intervention description(s): IV Magnesium sulphate 30 mg/kg, labeled as "research drug" for blinding, were given in 10 minutes while patients were monitored for side effects such as hypotension, bradycardia, nausea, vomiting, itch, allergy, drowsiness, and respiratory depression.; IV Meperidine 0.5 mg/kg, labeled as "research drug" for blinding, were given in 10 minutes while patients were monitored for side effects such as hypotension, bradycardia, nausea, vomiting, itch, allergy, drowsiness, and respiratory depression.
Intervention MeSH terms: Magnesium Sulfate; Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-pregnant patients between 18-65 years of age, belonging to the American Society of Anesthesiologist physical status I or II who underwent spinal anesthesia.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Magnesium sulphate; meperidine; shivering; spinal anesthesia