Effect of pre-emptive intravenous dexmedetomidine and paracetamol on post spinal shivering - Randomized double blind study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of shivering based on Tsai and Chu score.
研究概览
简要总结
Group A: iv Dexmedetomidine 1 μg/kg (diluted in 100 ml NS) and Group B: iv Paracetamol 1 g
•On arrival in the OT patients will be positioned in a supine position &
multipara monitors will be attached & baseline HR, NIBP, SpO2 & ECG will
be recorded. Baseline nasopharyngeal temp will be also noted. A large-
bore intravenous cannula will be inserted into forearm and pre-hydration
will be done with 500 ml RL which will be kept at room temperature
• Study drugs will be prepared and administered by Anaesthesiologist who
will not be involved in the study.
• Pre-medication: i.v Ondansetron 4 mg + study drug as per the group assigned 15 min prior to administration of SAB.
•The incidence and duration of shivering will be noted and graded at every 2
minutes after administration of SAB till 20 minutes & at every 5 minutes
thereafter till the completion of surgery. It will be based on Tsai and Chu score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and ІІ and III Age 18 to 60 years BMI less than 30 Patients undergoing elective lower abdominal surgery under SAB.
排除标准
- •Patients refusal to participate Insufficient blockade Any comorbidities like uncontrolled cardiovascular or cerebrovascular diseases, renal impairment, severe liver diseases, convulsion or psychiatric disorders, hypo/hyperthyroidism, DM & other autonomic disorders.
- •Allergy to study drugs Initial nasopharyngeal temp of more than 38 degree C or less than 35 degree C Sensory block above T6 Blood transfusion during surgery.
结局指标
主要结局
Incidence of shivering based on Tsai and Chu score.
时间窗: The incidence and duration of shivering will be noted and graded at every 2 | minutes after administration of SAB till 20 minutes & at every 5 minutes | thereafter till the completion of surgery. It will be based on Tsai and Chu score
次要结局
- • Grades of shivering(• Duration of shivering)
研究者
Dr Preeti Varma
Department of anaesthesiology and pain medicine, Pt. JNM Medical College Raipur, Chhattisgarh