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Prophylactic Tramadol Versus Magnesium Sulphate for Prevention of Post-Spinal Shivering

Sponsor: Punjab Rangers Teaching Hospital Lahore

Summary

This randomized controlled trial compared prophylactic intravenous tramadol and magnesium sulphate for the prevention of post-spinal shivering among women undergoing elective cesarean section under spinal anesthesia. The study was conducted in the Department of Anaesthesia, Punjab Rangers Teaching Hospital, Lahore, over six months from 10 October 2024 to 10 April 2025. A total of 106 pregnant women aged 18-40 years were enrolled following ethical approval, informed consent, and counseling. Participants were randomly allocated into two equal groups (n=53 each). Group A received tramadol 0.5 mg/kg intravenously, while Group B received magnesium sulphate 30 mg/kg intravenously. Both drugs were diluted in 100 mL isotonic saline and administered after spinal anesthesia. Standardized anesthetic techniques, perioperative monitoring, operating-room temperature, fluid co-loading, and postoperative observation were maintained. Patients with major cardiopulmonary, renal, or hepatic disease, thyroid disorders, pre-eclampsia, eclampsia, psychiatric illness, morbid obesity, significant blood transfusion or fluid administration, abnormal placental attachment, or relevant drug allergies were excluded. Spinal anesthesia was performed using 0.5% hyperbaric bupivacaine at the L3-L4 or L4-L5 interspace. Patients were monitored using ECG, non-invasive blood pressure, pulse oximetry, pulse rate, and temperature monitoring. Post-spinal shivering was defined as involuntary muscle activity lasting more than 15 seconds with a Crossley and Mahajan score of ≥2. The occurrence and severity of shivering were assessed, and adverse effects including nausea, vomiting, bradycardia, arrhythmia, and hypotension were recorded. Shivering was managed with warming, oxygen supplementation, or rescue medication when required. The primary outcome was the incidence of post-spinal shivering. Secondary outcomes included shivering severity and adverse effects. Data were analyzed using SPSS version 26. Continuous variables were assessed for distribution and summarized as mean ± standard deviation, while categorical variables were presented as frequencies and percentages. Between-group comparisons were performed using the independent-samples t-test for continuous variables where appropriate and the chi-square test or Fisher's exact test for categorical variables, according to expected cell frequencies. The primary outcome and other categorical outcomes were analyzed using chi-square or Fisher's exact test as appropriate. A two-sided p-value of ≤0.05 was considered statistically significant.

Official title: TRAM-MAGS: Tramadol Versus Magnesium Sulphate for Prevention of Post-Spinal Shivering in Elective Cesarean Section

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