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

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.

Timeline

Start

2024-10-10

Primary completion

2025-10-10

Completion

2025-10-10

Publications

• Results 1. Esmat IM, Mohamed MM, Abdelaal WA, El-Hariri HM, Ashoor TM. Postspinal anesthesia shivering in lower abdominal and lower limb surgeries: a randomized controlled comparison between paracetamol and dexamethasone. BMC Anesthesiol. 2021; 21:1-3. doi: 10.1186/s12871-021-01483-7. 2. Paliwal N, Khan IA, Paliwal Sr N. Exploring variability in spinal anesthesia levels achieved during cesarean section deliveries: a narrative review. Cureus 2025;17(7):e88429. doi: 10.7759/cureus.88429. 3. Jouryabi AM, Sharami SH, Ghanaie MM, Sedighinejad A, Imantalab V, Sorouri, ZR, et al. Comparing the effects of low dose of ketamine, tramadol, and ondansetron in prevention of post spinal anesthesia shivering in cesarean section. Anesth Pain Med. 2021; 11(4):e116429. doi: 10.5812/aapm.116429. 4. Kanchan S, Shah AM, Shah A, Sameen Z, Arya A, Riaz S, et al. Post spinal anaesthesia shivering-incidence and associated risk factors in patients undergoing lower limb and abdominal surgeries. Int J Res Med Sci. 2022; 10(10):2285-90. doi: 10.18203/2320-6012.ijrms20222536. 5. Qi X, Chen D, Li G, Cao J, Yan Y, Li Z, et al. Risk factors associated with intraoperative shivering during caesarean section: a prospective nested case-control study. BMC Anesthesiol. 2022; 22(1):56. doi: 10.1186/s12871-022-01596-7. 6. Feng G, Wang Y, Feng J, Luo X, Li C, Yao S. The relationship between core temperature and perioperative shivering during caesarean section under intrathecal anesthesia with bupivacaine and ropivacaine: a randomized controlled study. J Anesth. 2021; 35(6):889-95. doi: 10.1007/s00540-021-02995-9. 7. Low RG, Izaham A, Zain JM, Nor NM, Low HJ, Yusof AM. Prevention of shivering post subarachnoid block: comparison between different doses of intravenous magnesium sulphate. Medicina. 2022;58(8):1046. doi:10.3390/medicina58081046. 8. Pryambodho, Manggala SK, Sihombing M. Intravenous magnesium sulfate versus intravenous meperidine to prevent shivering during spinal anesthesia. Med J Indones. 2022; 31(2):1

Drugs

Indications

No indication recorded.