Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthesia Shivering
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Incidence and Severity of Post-Spinal Anesthesia Shivering
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries.
The main questions it aims to answer are:
- Does prophylactic intravenous tramadol reduce the incidence and severity of shivering more effectively than ketamine after spinal anesthesia?
- Are there differences in side effects, such as sedation or nausea, between tramadol and ketamine?
Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention.
Participants will:
- Be randomly assigned to receive either tramadol (1 mg/kg) or ketamine (0.5 mg/kg) five minutes after spinal anesthesia.
- Have their shivering severity assessed at 15, 30, 45, and 60 minutes using a standardized scale.
- Be monitored for sedation, nausea, and other possible side effects.
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
- Double (Care Provider, Investigator)
盲法说明
The study medications were prepared in identical syringes by an independent anesthesiologist not involved in patient care to maintain blinding. Both the anesthesia providers and outcome assessors were blinded to group allocation throughout the study.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 20 to 65 years,
- •American Society of Anesthesiologists (ASA) Physical Status I or II, and
- •Scheduled for elective lower abdominal or inguinoscrotal surgeries
- •Under spinal anesthesia were included
排除标准
- •Thyroid or neuromuscular disorders,
- •History of chronic sedative or narcotic use,
- •Requiring intraoperative blood transfusion
- •Had a baseline body temperature greater than 38°C or less than 36°C,
- •Undergoing transurethral resection of the prostate (TURP).
研究组 & 干预措施
Tramadol Group
Patients in this group receive intravenous tramadol 1 mg/kg five minutes after the administration of spinal anesthesia. The intervention is administered in a double-blind manner using identical syringes prepared by an independent anesthesiologist.
干预措施: Tramadol (Drug)
Ketamine Group
Patients in this group receive intravenous ketamine 0.5 mg/kg five minutes after spinal anesthesia, using identical administration procedures to maintain blinding.
干预措施: Ketamine (Drug)
结局指标
主要结局
Incidence and Severity of Post-Spinal Anesthesia Shivering
时间窗: Up to 60 minutes post spinal anesthesia
The incidence and severity of shivering will be assessed using the Bedside Shivering Assessment Scale (BSAS) at 15, 30, 45, and 60 minutes following the administration of spinal anesthesia. BSAS Grading: * 0 = No shivering * 1 = Piloerection or peripheral vasoconstriction without visible shivering * 2 = Visible muscular activity confined to one muscle group * 3 = Gross muscular activity involving the entire body
次要结局
- Sedation Score(Up to 60 minutes post spinal anesthesia)
- Incidence of Postoperative Nausea and Vomiting (PONV)(Up to 60 minutes post spinal anesthesia)
研究者
Syed Muhammad Abbas
Professor
Sindh Institute of Urology and Transplantation