跳至主要内容
临床试验/NCT02063620
NCT02063620已完成不适用

The Effect of Different Anesthetic Agents Management on Electrocardiographic Changes of Patients Who Were Operated Under Regional Intravenous Anesthesia

Duzce University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
QT and QTc intervals

研究概览

简要总结

IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus ketamine.

详细描述

Methods: Patients between 18-60 years, with score of ASA 1-2 and who were undergoing IVRA for short operations on arm and forearm were included. Systolic, diastolic and mean blood pressures, heart rate, SpO2, ECG, adverse effects during the operation were recorded. Double cuffed tourniquet were placed on the extremity to be operated to hinder nerve injuries. Venous blood in the extremity was purged with Esmarch bandage. Proximal cuff was inflated with a pressure 50-100 mmHg higher than systolic blood pressure and the bandage was displaced. Randomly patients were divided into 2 groups. Group 1: %0.5 Lidocaine+Ketamine 0.8 mg/kg; 40 ml. Group 2: %0.5 Lidocaine 40 ml. Anesthetic agent was injected with a rate of 20 ml/min. 20 minutes after injection the distal cuff was inflated and the proximal cuff deflated with a rate of 50 mmHg in every 3 minutes. 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18-60 years
  • ASA 1-2 physical status
  • Undergoing IVRA for short operations on arm and forearm

排除标准

  • Allergy to study drugs,
  • Serious cardiac diseases,
  • Respiratory diseases,
  • Renal failure,
  • Drug addiction,
  • Liver failure,
  • Hypertension,
  • Genetic diseases of musculoskeletal system,
  • Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.

研究组 & 干预措施

ketamine HCL

Active Comparator

%0.5 Lidocaine+Ketamine HCL 0.8 mg/kg, total 40ml, single dose administration, 30 minute duration, total 200mg lidocaine

干预措施: Ketamine HCL (Drug)

结局指标

主要结局

QT and QTc intervals

时间窗: Change QT and QTc intervals from baseline to 60 minutes

0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.

次要结局

  • mean arteryel pressure(Change of mean arteryel pressure from baseline to 60 minutes)

研究者

发起方
Duzce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilknur Suidiye

assistant professor

Duzce University

研究点 (1)

Loading locations...

相似试验