Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05110469 |
| Other study ID # |
MagnesiumAS01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
AnestesiaR |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
