Comparison of MgSO4 Versus Meperidine for Prevention of Shivering During Spinal Anesthesia

NCT05110469 | Completed Phase 4 DMC

• 1 other identifier: MagnesiumAS01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shivering

Keywords

Magnesium sulphate; meperidine; shivering; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Drug effectiveness

  Drugs were considered effective if they could prevent the incidence of 3rd or 4th degree shivering

  120 minutes

Study Arms (2)

Group M

EXPERIMENTAL

IV Magnesium sulphate 30 mg/kg in 100 ml NaCl 0.9%

Drug: Magnesium sulfate

Group P

EXPERIMENTAL

IV Meperidine 0.5 mg/kg in 100 ml NaCl 0.9%

Drug: Meperidine

Interventions

Magnesium sulfate DRUG

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.

Group M

Meperidine DRUG

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.

Group P

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years old
• American Society of Anesthesiologist (ASA) physical status I or II
• Planning for spinal anesthesia

You may not qualify if:

• History of allergy to the drugs used in the study
• Pregnant patients
• With neuromuscular disease, hyperthyroid, severe cardiopulmonary diseases, liver and/or renal disorders
• Used drugs that could interact with MgSO4 such as nifedipine
• Preoperative body temperature less than 36oC or more than 37.5oC

Sponsors & Collaborators

• AnestesiaR: lead

Study Sites (1)

Dr. Cipto Mangunkusumo National General Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Magnesium Sulfate; Meperidine

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient allocation was done by randomization by anesthesiologists outside of the research team using randomization software. Patients would be divided into two groups, namely group M which contains MgSO4 30 mg/kg i.v. and group P which contains meperidine 0.5 mg/kg i.v. Anesthesiologists outside of the research team would prepare the study drug according to the randomized group. The formulated drug would be labeled as research drug without mentioning the content or group of the drug. Prior to spinal anesthesia, another OK team outside of the research team would give the research drug without knowing the contents of the drug, as well as perform spinal anesthesia. Observation of the data would be carried out by the researcher together with the OR team who performed the spinal anesthesia.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 8, 2021
• Study Start: February 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)