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临床试验/NCT03926000
NCT03926000Unknown不适用

The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy

Menoufia University0 个研究点目标入组 112 人开始时间: 2019年6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
入组人数
112
主要终点
Total amount of anesthetics

研究概览

简要总结

Outpatient arthroscopic knee surgery can be performed with general or regional anesthesia. Recent data suggest that spinal and epidural anesthesia require longer discharge times than the newer shorter-acting general anesthetic drugs. Ideal premedication drug should relieve anxiety, produce amnesia and sedation, decrease secretions, prevent nausea and vomiting, have dose sparing effect on the anaesthetic drugs, and suppress pressor response to laryngoscopy and intubation. Recently, gabapentin and pregabalin were suggested as pre-operative drugs to decrease anxiety, stress response to laryngoscopy and post operative pain.

详细描述

112 patients undergoing elective knee arthroscopy will randomly divided into two equal groups, 56 patients each. All patients will receive premedication one hour before the procedure. PG group will receive 150 mg pregabalin and C group will receive placebo. All patients will receive total intravenous anesthesia to achieve optimum working conditions. Intra-operative total amount of anesthetics will be compared in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective knee arthroscopy.
  • Patients aged between 21 and 50 years old.
  • Patients with American Society of Anaesthesiologists physical status I or II.

排除标准

  • Patients with known allergy to any drug used in the study.
  • Patients with chronic use of analgesics and/or sedatives.
  • Patients with sleep apnea syndrome.
  • Patients with renal or hepatic dysfunction.
  • Patients with psychiatric disorders.

研究组 & 干预措施

Pregabalin (PG)

Active Comparator

Patients will receive 150 mg pregabalin one hour before the procedure.

干预措施: Pregabalin (PG) (Drug)

Control placebo (C)

Placebo Comparator

Patients will receive placebo tablet one hour before surgery.

干预措施: Control placebo (C) (Drug)

结局指标

主要结局

Total amount of anesthetics

时间窗: 45 minutes during the procedure

Total amount of anesthetics used during the procedure.

次要结局

  • Patients' satisfaction: satisfaction score(30 minutes after the end of the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Ezzeldin Ibrahim

Professor

Menoufia University

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