TRAM-MAGS: Tramadol Versus Magnesium Sulphate for Prevention of Post-Spinal Shivering in Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Incidence of post-spinal shivering
研究概览
简要总结
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.
详细描述
This randomized controlled trial was conducted to compare the effectiveness of prophylactic intravenous tramadol with intravenous magnesium sulphate for prevention of post-spinal shivering in women undergoing elective cesarean section under spinal anesthesia. The study was conducted in the Department of Anaesthesia, Punjab Rangers Teaching Hospital, Lahore, over a period of six months from 10 October 2024 to 10 April 2025.
Spinal anesthesia is widely used for cesarean section because of its rapid onset, reliability, avoidance of airway manipulation, and favorable maternal and neonatal safety profile. However, post-spinal shivering is a relatively common complication and may cause considerable discomfort and anxiety for the patient. Shivering may also interfere with monitoring and may increase oxygen consumption and metabolic demand. Various pharmacological agents have therefore been investigated for prevention and treatment of shivering associated with neuraxial anesthesia. Tramadol has been used as an anti-shivering agent because of its central effects on serotonergic and noradrenergic pathways, while magnesium sulphate may reduce shivering by influencing neuromuscular transmission and lowering the shivering threshold. Previous comparative studies have reported conflicting results regarding the effectiveness of these agents in patients undergoing cesarean section under spinal anesthesia. The present study was therefore undertaken to compare the two agents under standardized perioperative conditions.
A total of 106 pregnant women scheduled for elective cesarean section were enrolled after obtaining ethical approval and written informed consent. Eligible participants were women aged 18 to 40 years undergoing elective cesarean section under spinal anesthesia. Participants were selected through non-probability consecutive sampling. Patients were excluded if they had severe systemic disease involving the cardiopulmonary, renal, or hepatic systems; thyroid disorders; pre-eclampsia or eclampsia; psychiatric illness; morbid obesity; significant intraoperative blood transfusion or excessive fluid administration; abnormal placental attachment; or allergy to any of the study medications.
After enrollment, participants were randomly allocated into two equal groups of 53 patients each. Group A received tramadol at a dose of 0.5 mg/kg intravenously, while Group B received magnesium sulphate at a dose of 30 mg/kg intravenously. In both groups, the assigned study medication was diluted in 100 mL isotonic saline and administered after establishment of spinal anesthesia. Standardized drug doses and similar perioperative conditions were used to ensure comparability between the treatment groups.
All participants received standard preoperative medications and anesthetic management according to the institutional protocol. Preoperative medications included oral ranitidine 150 mg and metoclopramide 10 mg on the night before surgery, with intravenous medications administered before anesthesia as per protocol. Spinal anesthesia was performed in the sitting position using a 25- or 26-gauge Quincke needle at the L3-L4 or L4-L5 intervertebral level. A dose of 2.0-2.2 mL of 0.5% hyperbaric bupivacaine was used for the spinal block. Ringer lactate was administered as a co-load at 10 mg/kg according to the study protocol. The operating-room temperature was maintained at approximately 24-25°C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between 18 and 40 years age and undergoing elective cesarean section will be enrolled in the study.
排除标准
- •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.
研究组 & 干预措施
Magnesium Sulphate Group
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.
干预措施: Magnesium Sulphate (Drug)
Tramadol Group
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.
干预措施: Tramadol (Drug)
结局指标
主要结局
Incidence of post-spinal shivering
时间窗: From administration of spinal anesthesia until the end of the surgical procedure-Last Stitch
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.
次要结局
- Severity of post-spinal shivering(From administration of spinal anesthesia until the end of the surgical procedure-Last Stitch)
研究者
Ayesha Jamal
Dr.
Punjab Rangers Teaching Hospital Lahore