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临床试验/CTRI/2021/06/034333
CTRI/2021/06/034333尚未招募4 期

Randomised controlled trial to compare cisatracurium versus 2%lignocaine preservative free (xylocard) pretreatment with tourniquet to reduce propofol injection pain

Department of Anaesthesia Panjab institute of medical sciences Jalandhar2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月22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
80
试验地点
2
主要终点
Efficacy of cisatracurium with 2% xylocard pretreatment to reduce propofol injection pain

研究概览

简要总结

AIMSAND OBJECTIVES

 â—       The aim of thepresent study is to investigate the efficacy of pretreatment with 0.15mg/Kg   cisatracurium in the prevention of propol-associated pain injected 30s before propofol injection with venous occlusion athe forearm. The efficacy of cisatracurium will compared with that of 2%preservative free lidocaine

MATERIAL AND METHODS

•          Thisopen label prospective, randomized controlled study will be done at PIMS,Jalandhar after approval from institutional ethics committee on 80 patients(40patients for each group) scheduled to undergo elective non cardiac surgeryunder general anesthesia of ASA physical status I and II aged 18-65 years.

•       Exclusion Criteria: Patient refusal,Allergy to propofol or egg, limited neck mobility; history of difficultintubation; history of cardiovascular, respiratory, neurological, neuromuscularor psychiatric disease.

•      Patients will be randomly divided into two groupsaccording to computer generated randomization.

•      Group-I:- Pretreatment with 2% Lignocaine 0.5mg/Kg(Preservative free)

•      Group-II: - Pretreatment with 0.15mg/Kg cisatracurium.

•       Patient will be taken to the operative room andECG, SPO2, NIBP will be recorded.

•      A 20-G cannula will be inserted into the largestvisible vein on the radial side, attached to a three-way tap and flushed withRinger’s lactate solution.

•      A venous occlusion tourniquet will be applied justabove the elbow and pretreatment drug will be administered in open labelmanner. The tourniquet will be released after 30s. Then 0.5mg/kg propofol willbe delivered via the intravenous cannula. In order to evaluate pain anddetermine the possibility of muscle paralysis, patients will be asked “does ithurt?†by the anesthetist at 10s after the initial propofol dose, and at 20sintervals thereafter until unresponsive. Any spontaneous movement of the wrist,elbow or shoulder will be noted. Pain scores will be evaluated by ananesthetist who will be blinded to group assignment and expressed using afour-point scale:

STATISTICAL ANALYSIS

•      Continuous variables will be expressed as mean ±SD ormedian (range). Categorical variables were described as n (%).

•      Demographic data will be analyzed with one wayanalysis of variance and Scheffe’s post hoc test, or X2-test.

•       Between- groupvariation in the incidence of pain will be analyzed using X2-test.Statistical significant will be defined as P<0.05. Statistical analyses willperformed with SPSS.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for elective surgery.

排除标准

  • Patient refusal Allergy to propofol, egg History of cardiovascular, respiratory dysfunction History of difficult intubation.

结局指标

主要结局

Efficacy of cisatracurium with 2% xylocard pretreatment to reduce propofol injection pain

时间窗: Single

次要结局

  • Any adverse effects,(nausea, vomiting, muscle paralysis, diplopia, anaphylaxis) of both these drugs(Single)
  • Any adverse effects (nausea , vomiting , muscle paralysis, diplopia, anaphylaxis) of cisatracurium and 2%xylocaine preservative free during study cisatracurium(Single)

研究者

发起方
Department of Anaesthesia Panjab institute of medical sciences Jalandhar
申办方类型
Private medical college

研究点 (2)

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