Comparative Study Of The Effect Of Dexmedetomidine And Butorphanol On Post-Spinal Anesthesia Shivering
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare efficacy of intravenous dexmedetomidine and buterphenol for control of shivering after spinal anaesthesia
研究概览
简要总结
AIM: To evaluate and compare the efficacy of intravenous Dexmedetomidine and Butorphanol for control of shivering afterspinal anesthesia.
As control of perioperative shivering is of paramount importance and there are very few studies available on literature search comparing anti-shivering efficacy of Dexmedetomidine and Butorphanol in control of post-anesthetic shivering that’s why we decided to do this comparative study.
GRADE I: No shivering observed.
GRADE II: Mild Shivering, slight facial and cervical muscle contraction
GRADE III: Moderate Shivering, obvious shivering in the head and neck, shoulders and /or extremities
GRADE IV: Severe Shivering, obvious shaking all over the body.
Only supplemental oxygen will be given to patients who develops shivering of GRADE I, at the rate of 5L/Min with face mask. Patients will be covers with drapes but not actively warmed.
Patients who develops either GRADE II to IV shivering included in study. These patients apart from supplemental oxygen and covering with drapes, will be randomly administered either inj. Dexmedetomidine 0.5mcg / kg diluted in 10 ml Normal Saline given IV slowly over 10 minutes or, inj. Butorphanol 0.01mg / Kg diluted in 10 ml Normal Saline given slowly over 10 min. Time taken for cessation of shivering, recurrence of shivering, hemodynamic status and sedation scores are observed from 1 min to 5 min and then 10min ,20min,30min and 60 min .
Shivering control is defined as:
Complete :when shivering score declines to 0,
Incomplete: when the scores decreases but did not abolish the shivering completely
Failed: if no change in scores observes.
Episodes of recurrence or incomplete control will be treated with active warming measures such as warmer (body warmer and fluid warmer), or multimodal therapy Inj. Ketamine 0.5mg/kg IV and/or Inj.Dexona 8mg IV.
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 GRADE I, II, III.
排除标准
- •Refusal of patients
- •Patients with an initial body (core) temperature more than 38 degree celsius or less than 36 degree Celsius.
- •Patients with relative and absolute contraindication to spinal anesthesia
- •Allergic to any study drug.
结局指标
主要结局
Compare efficacy of intravenous dexmedetomidine and buterphenol for control of shivering after spinal anaesthesia
时间窗: Assess Shivering score from Grade 1(No shivering) to Grade 4(Severe shivering) at 1min,2min,3min,4min,5min,6min, | 7min,8min,9min,10minute | Ramsay sedation score at 1min,2min,3min,4min,5min,10min, | 15min,30min,60 minute | Hemodynamic changes 1min,2min,3min,4min,5min,10min
次要结局
- Sedation score(Hemodynamic changes(HR,BP,SPO2,RR))
研究者
Sanju Prajapati
Pandit Deendayal Upadhyay Medical College, Rajkot
