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临床试验/NCT05898061
NCT05898061招募中不适用

Optimal Lidocaine Propofol Mixture for Painless Induction of Anesthesia

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Pain scale

研究概览

简要总结

This research will be carried out in order to determine the optimal lidocaine dose in propofol lidocaine mixture to prevent pain on propofol injection during induction of general anesthesia using a modified Dixon's up-and-down method. Patients & methods: Include assessment of severity of pain on propofol injection using seven doses of lidocaine in lidocaine propofol mixture in ASA I&II patients aged 18-60 years with exclusion of patients with history of drug allergy, hepatic or renal impairment, cardiac problems, neurologic deficits or psychiatric disorders.

The primary outcome will be pain scale during injection and volume of propofol-lidocaine mixture used. Secondary outcome will be increase in heart rate and/or hand or forearm withdrawal during injection, patient satisfaction, demographic data, type and duration of surgery, Time for unconsciousness.

Aim of the work: To determine the Minimal effective dose of lidocaine in propofol lidocaine mixture to achieve painless induction of anesthesia using propofol.

详细描述

Rapid onset of action, smooth induction, favorable recovery and low rate of adverse effects have made propofol the most commonly used intravenous anesthetic for induction and maintenance of anesthesia. However, pain associated with propofol injection is still considered by many patients as the worst prioperative unpleasant experience.1 Therefore, a diversity of techniques have been suggested in the literature to solve this problem including pretreatment with local anesthetics, opiates, ketamine and alfentanil. 2-5 New propofol formulation was another way to alleviate this pain.6 Among these techniques lidocaine was investigated extensively whether as a pretreatment with the use of tourniquet, which is a time consuming technique, or mixed with propofol. Evaluation of optimal dose of lidocaine in propofol lidocaine mixture was widely assessed. However, evaluation of optimal lidocaine dose in propofol lidocaine mixture to prevent pain with newer formulations of propofol should be further evaluated. We hypothesize that optimal dose of lidocaine to alleviate pain with propofol injection might need further evaluation.

Patients and methods

This prospective randomized and double blinded study will be conducted in Sohag University Hospital after obtaining approval from Institutional Review Board and written informed consent from all patients before enrolment in this study. Patients scheduled for elective surgery under general anesthesia, aged 18 to 60 years and American Society of Anesthesiologists (ASA)physical status I & II will be selected for this study. Patients with history of drug allergy, hepatic or renal impairment, cardiac problems, neurologic deficits, psychiatric disorders or anxious patients who need sedation preoperatively will be excluded from the study.

Before entering the operating room premedication will not be allowed. In the operating room 20 gauge cannula will be inserted into a vein on the dorsum of the non-dominant hand & basic monitoring (pulse oximetry, electrocardiography, noninvasive blood pressure & end tidal carbon dioxide) will be applied to the patient before induction and throughout the procedure.

Mixtures of propofol, lidocaine and saline will be prepared by an anesthetist who is not involved in the study team according to the lidocaine dose sequence as shown in table (1) resulting into eight mixtures. The mixture will be injected at a rate of 20ml/minute using syringe pump until patient loose consciousness. The anesthetist who inject the propofol and the patient will be blinded to the lidocaine dose in the mixture.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

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 scheduled for elective surgery under general anesthesia.
  • Aged 18 to 60 years
  • American Society of Anesthesiologists physical status I & II
  • Exclusion Criteria
  • History of drug allergy
  • Hepatic or renal impairment .Cardiac disease
  • Neurologic deficits ,psychiatric disorders
  • Anxious patients who need sedation preoperatively

排除标准

  • 未提供

结局指标

主要结局

Pain scale

时间窗: 9 months

Pain scale (mild, moderate or severe) during injection of propofol

次要结局

  • patient satisfaction(30 minutes after recovery)
  • time for unconsciousness(2 minutes after start of injection of propofol)
  • Heart rate(Before injection of propofol-lidocaine mixture and every minute for three minutes after start of injection)
  • hand or forearm withdrawal(2 minutes duration during injection of propofol)

研究者

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

Fawzy Abbas Badawy

Optimal lidocaine propofol mixture for painless induction of anesthesia

Sohag University

研究点 (1)

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