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

NCT07838662 | Completed DMC

• 1 other identifier: PRTH-Lahore
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-spinal Shivering

Keywords

Magnesium Sulfate, Tramadol, Shivering, Anesthesia Spinal

Outcome Measures

Primary Outcomes (1)

• Incidence of post-spinal shivering

  Occurrence of post-spinal shivering following spinal anesthesia, defined as involuntary spontaneous muscle hyperactivity lasting more than 15 seconds with a Crossley and Mahajan shivering scale score ≥2.

  From administration of spinal anesthesia until the end of the surgical procedure-Last Stitch

Secondary Outcomes (1)

• Severity of post-spinal shivering

  From administration of spinal anesthesia until the end of the surgical procedure-Last Stitch

Other Outcomes (1)

• Adverse effects

  From administration of the study drug until the end of the intraoperative observation period.

Study Arms (2)

Tramadol Group

EXPERIMENTAL

Participants in this group received prophylactic intravenous tramadol at a dose of 0.5 mg/kg after administration of spinal anesthesia. The drug was diluted in 100 mL isotonic saline and administered according to the study protocol. Standardized spinal anesthesia, perioperative monitoring, operating-room temperature, fluid co-loading, and postoperative observation were provided. Post-spinal shivering was assessed using the Crossley and Mahajan scale, and its occurrence and severity were recorded.

Drug: Tramadol

Magnesium Sulphate Group

ACTIVE COMPARATOR

Participants in this group received prophylactic intravenous magnesium sulphate at a dose of 30 mg/kg after administration of spinal anesthesia. The drug was diluted in 100 mL isotonic saline and administered according to the study protocol. Standardized spinal anesthesia, perioperative monitoring, operating-room temperature, fluid co-loading, and postoperative observation were provided. Post-spinal shivering was assessed using the Crossley and Mahajan scale, and its occurrence and severity were recorded.

Drug: Magnesium Sulphate

Interventions

Magnesium Sulphate DRUG

Magnesium sulphate 30 mg/kg intravenously in 100 mL isotonic saline after spinal anesthesia for prevention of post-spinal shivering.

Also known as: MgSO₄

Magnesium Sulphate Group

Tramadol DRUG

Tramadol 0.5 mg/kg intravenously in 100 mL isotonic saline after spinal anesthesia for prevention of post-spinal shivering.

Also known as: Tramadol HCl

Tramadol Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between 18 and 40 years age and undergoing elective cesarean section will be enrolled in the study.

You may not qualify if:

• Patients with severe cardiopulmonary, renal, or liver disease, pre-eclampsia, eclampsia, hypo- or hyperthyroidism.
• Patients with psychiatric disorders or morbid obesity.
• Patients who have received blood transfusion or \>2,000 mL fluid intraoperatively.
• Patients with placenta accreta or placenta percreta.
• Patients allergic to either study drug.

Sponsors & Collaborators

• Punjab Rangers Teaching Hospital Lahore: lead

Study Sites (1)

Department of Anaesthesia

Lahore, Punjab Province, 54810, Pakistan

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Interventions

Tramadol; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This is a randomized, parallel-group controlled trial involving 106 pregnant women undergoing elective cesarean section under spinal anesthesia. Participants were randomly allocated in a 1:1 ratio into two groups of 53 patients each. Group A received prophylactic intravenous tramadol 0.5 mg/kg, while Group B received prophylactic intravenous magnesium sulphate 30 mg/kg, with each drug diluted in 100 mL isotonic saline and administered after spinal anesthesia. Both groups received standardized anesthetic management and perioperative monitoring. The primary outcome was the occurrence of post-spinal shivering, with severity assessed using the Crossley and Mahajan shivering scale. The groups were compared to determine which prophylactic intervention was more effective in preventing post-spinal shivering.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 24, 2026
• Study Start: October 10, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)