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

NCT05110469 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-11-08

No results posted yet for this study

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

Interventions

DRUG

Magnesium sulfate

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.

DRUG

Meperidine

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.

Sponsors & Collaborators

  • AnestesiaR

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110469 on ClinicalTrials.gov