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临床试验/NCT06175156
NCT06175156已完成不适用

The Application of Propofol and Remifentanil Mixed Solution for Controlled Sedation and Analgesia in Fiber Colonoscopy

Handan First Hospital1 个研究点 分布在 1 个国家目标入组 80 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
已完成
发起方
入组人数
80
试验地点
1
主要终点
Auditory evoked potential

研究概览

简要总结

Fiber colonoscopy, as a terminal examination method for lower gastrointestinal diseases, often brings varying degrees of pain, discomfort, tension, and anxiety to patients. Therefore, currently in clinical practice, intravenous anesthesia is often chosen to reduce discomfort. At present, intravenous propofol and fentanyl are most widely used in clinical practice, but intravenous general anesthesia can lead to hemodynamic fluctuations and an increase in anesthesia related complications such as prolonged hospital stay after surgery. Propofol and remifentanil have the characteristics of fast onset, short duration of action, and rapid awakening. The purpose of this study is to observe the efficacy and adverse reactions of remifentanil combined with low-dose propofol in patient-controlled analgesia and sedation during colonoscopy, in order to explore the safety and effectiveness of this method.

详细描述

Fibercolonoscopy, as a terminal examination method for lower digestive tract diseases, often brings different degrees of pain and discomfort, tension and anxiety to patients. Therefore, at present, intravenous anesthesia is often used in clinical practice to reduce discomfort, and intravenous propofol combined with fentanyl is the most widely used in clinical practice. But intravenous general anesthesia can lead to hemodynamic fluctuations and an increase in anesthesiation-related complications such as longer stays in the hospital after surgery. Complications related to sedation and analgesia have attracted increasing attention in recent years. Studies have shown that most of the adverse events in endoscopy are related to the sedation and analgesia drugs used. With the successful application of patient-controlled analgesia (PCA) in the field of postoperative analgesia, this technique has also been used in the sedation and analgesia of gastroenteroscopy in recent years. Propofol has the characteristics of quick action, short time of action and rapid recovery, so it is very suitable for the anesthesia and sedation of painless abortion and painless gastroenteroscopy. Remifentanil, as an opioid μ receptor agonist, is easily hydrolyzed rapidly by non-specific esterases in plasma and tissues due to the ester bond contained in its chemical structure. Therefore, it has unique pharmacokinetic characteristics such as rapid intravenous injection, small volume of distribution, rapid clearance after drug withdrawal, no accumulation, metabolism is not affected by liver and kidney function, and has been widely used in various surgeries in recent years, especially in the anesthesia of short surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) Grade I - II;
  • Age 18-75 years old;
  • Body mass index (BMI) <25㎏/㎡;
  • no mental and nervous system diseases;

排除标准

  • Refusal to cooperate or difficulty communicating;
  • History of drug allergy;
  • Long-term alcoholism and dependence on stabilizing and opioid drugs;
  • Patients with past history of intestinal surgery or past difficulty in endoscopic surgery;
  • People with hearing impairment

结局指标

主要结局

Auditory evoked potential

时间窗: through study completion,an average of 2 hours

The auditory evoked potential (AEPI) is a reactive electrical activity of the brain generated by auditory stimuli, reflecting the entire electrical activity from the cochlea to the cerebral cortex.Before taking anesthesia, check Record the AEPI values at 5 time points before anesthesia, at the beginning of the examination, during endoscopy to the splenic curvature, ileocecal region, and at the end of the examination.

次要结局

  • The time from after surgery to OAA/S score reached 5 and Aldrete score reached 9(through study completion,an average of 2 hours)

研究者

发起方
Handan First Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yonghua Song

Director of Anesthesiology Department

Handan First Hospital

研究点 (1)

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