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临床试验/NCT04472689
NCT04472689Unknown不适用

Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery: Randomized Controlled Study

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
quality of postoperative recovery

研究概览

简要总结

The essential anesthesia requirements for FESS include airway management, considerations for facilitating surgical access, provision of a clear and still surgical field for precision surgery, assuring quick and non-stimulating emergence from anesthesia, and fast-tracking patients for discharge. Postoperative agitation, although short-lived, is potentially harmful to both patients and recovery room staff, it has a potential for self-injury by removing intravenous catheters, tubing, oxygen masks and nasal packs. Furthermore, very agitated patients can pose an immediate danger to operating theatre staff.

详细描述

Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life, and a favorable safety profile, and is therefore the LA of choice for continuous IV administration, it has analgesic, and anti-inflammatory effects that are induced by reduction of cytokines production through inhibition of neutrophil activation, and the analgesia may persist even after plasma concentration reduction. It can blunt the pressor response to endotracheal intubation also systemic lidocaine was effective in producing controlled hypotension.

研究设计

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

入排标准

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

入选标准

  • Patients scheduled for elective functional endoscopic sinus surgery;
  • ASA class I-II,
  • aged (20-60 years).

排除标准

  • Body mass index >35 kg/m2
  • History of allergic reaction to local anesthetic agents especially lignocaine.
  • History of preoperative use of opioids.
  • Patients with history of uncontrolled hypertension, A-V conduction block.
  • History of sleep apnea.

研究组 & 干预措施

Lidocaine group

Active Comparator

patients will receive a loading dose of IV lidocaine 1.5mg/kg slowly diluted with 20 ml normal saline just before induction of anesthesia, then the lidocaine infusion started at a rate of 2mg/kg/h diluted in normal saline by rate of 2 ml/ kg/h.

干预措施: Lidocaine (Drug)

Control group

Placebo Comparator

patients will receive an equal volume of normal saline (both the loading, and the infusion). The infusion in both groups will be started just after induction of anesthesia induction, and continued until the end of the operation.

干预措施: Normal saline (Drug)

结局指标

主要结局

quality of postoperative recovery

时间窗: 48hours

assessed using the Quality of Recovery-40 questionnaire.8, which assesses five dimensions of recovery

Emergence agitation

时间窗: 30 minutes postoperative

using the Richmond agitation-sedation scale

次要结局

未报告次要终点

研究者

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

rehab zayed

Assisstant Professor of Anesthesia

Alexandria University

研究点 (1)

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