跳至主要内容
临床试验/CTRI/2024/03/064924
CTRI/2024/03/064924尚未招募4 期

Comparative Study Of The Effect Of Dexmedetomidine And Butorphanol On Post-Spinal Anesthesia Shivering

Pandit Deendayal Upadhyay Medical College Rajkot1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月10日最近更新:

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

发起方
Pandit Deendayal Upadhyay Medical College Rajkot
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sanju Prajapati

Pandit Deendayal Upadhyay Medical College, Rajkot

研究点 (1)

Loading locations...

相似试验

The Effect Of Dexmedetomidine And Butorphanol After... | 临床试验