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临床试验/NCT05485064
NCT05485064已完成不适用

Moderate Sedation Combined With Acupuncture Anesthesia in Gastroscopy and Colonoscopy on Screening Research

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年8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
状态
已完成
入组人数
108
试验地点
1
主要终点
patient satisfaction with sedation instrument,PSSI

研究概览

简要总结

The purpose of this study is mainly about the feasibility and rationality of moderate sedation combined with acupuncture anesthesia in the application of gastroscopy and colonoscopy ,Then we evaluate the effectiveness and advantages of the combination of acupuncture anesthesia and drug anesthesia.

详细描述

With the increase of the proportion of the patients who crave for performing painless gastroscopy and colonoscopy in recent years, it is crucial to seek a more secure and effective method of anesthesia or sedation. At present, the universal anesthetic method on gastroscopy and colonoscopy in China is the general anesthesia without intubation which usually uses propofol and opioid analgesics,Although the satisfaction of patients is high, the incidence of anesthesia-related complications and drug-related adverse reactions is high .The incidence of adverse events during the gastroscopy and colonoscopy is high, and the medical expense of anesthesia is high. At present, more than 2/3 of the patients undergo painless gastroscopy or colonoscopy are middle-aged and elderly patients, so the overdose which prolongs the recovery time、discharge time of patients and reduces the recovery quality of patients is common. The moderate sedation, which fundmentally does not affect hemodynamics、autonomous respiration and protective reflexes, is incomparable to general anesthesia . And acupuncture anesthesia also acts as a safe anesthetic method can provide safer analgesic effect.Theoretically,the combination of both of them is a relatively perfect and safe painless method.

研究设计

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

盲法说明

During the examination, the acupuncture position was blocked to ensure that the acupuncture position was not visible; except for researcher 1, the only researcher who knew about the grouping of patients,All trial-related data were recorded by researcher 2 , and researcher 1 was responsible for patients'sedation.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients
  • Patients with ASA grade I-III
  • A sufficient level of education to understand study procedures and can communicate with investigators.

排除标准

  • Patients with serious systemic diseases such as severe cardiopulmonary disease or hepatic diseases or renal diseases.
  • Patients under the age of
  • Patients who did not sign the informed consent form.
  • Patients who have a history of alcohol abuse or drug abuse.
  • People who are allergic to anesthetic related ingredients, such as soybeans, eggs and so on.
  • Patients with extreme fear or anxiety about acupuncture.
  • Patients with relative contraindications of gastrointestinal endoscopy.

研究组 & 干预措施

electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam

Experimental

The investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

干预措施: eletroacupuncture(transcutaneous electrical acupuncture point stimulation ) (Procedure)

electroacupuncture(transcutaneous electrical acupuncture point stimulation )and remimazolam

Experimental

The investigator 1 combine electroacupuncture(transcutaneous acupoint electrical stimulation ) with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

干预措施: remimazolam (Drug)

placebo needle and remimazolam

Experimental

The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

干预措施: placebo needle (Drug)

placebo needle and remimazolam

Experimental

The investigator 1 combine placebo needle with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

干预措施: remimazolam (Drug)

fentanyl and remimazolam

Experimental

The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

干预措施: fentanyl (Drug)

fentanyl and remimazolam

Experimental

The investigator 1 combine fentanyl with remimazolam to sedate patients moderately to finish gastroscopy and colonoscopy.

干预措施: remimazolam (Drug)

结局指标

主要结局

patient satisfaction with sedation instrument,PSSI

时间窗: During gastroscopy and colonoscopy

The investigator 2 needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted gastroscopy and colonoscopy .The score ranges from 0 to10 and need patients evaluate it by themself when the gastroscopy or colonoscopy were finished.The score from 0 (extremely dissatisfied)to 10(extremely satisfied).

clinical satisfaction with sedation instrument,CSSI

时间窗: During gastroscopy and colonoscopy

The investigator 2 needs to use VAS scores to evaluate satisfaction about doctors when they carry out the operation.The score from 0 (extremely dissatisfied)to 10(extremely satisfied).

patient's pain score

时间窗: During gastroscopy and colonoscopy

The investigator 2 needs to use VAS scores to evaluate patients' pain score .The score from 0 (extremely dissatisfied)to 10(extremely satisfied).

次要结局

  • patient's recovery time(The end of gastroscopy and colonoscopy)
  • patient's departure time(The end of gastroscopy and colonoscopy)
  • respiratory rate(before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy)
  • operation time about gastrointestinal endoscopy(During gastroscopy and colonoscopy)
  • heart rate(before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy)
  • pulse oximetry(before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy)
  • systolic pressure 、diastolic pressure(before gastrointestinal endoscopy、during gastrointestinal endoscopy and the end of gastrointestinal endoscopy)
  • the extent of cardia exposure(During gastroscopy and colonoscopy)
  • adverse reactions(During gastroscopy and colonoscopy)
  • time to resume normal operation(The end of gastroscopy and colonoscopy)

研究者

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

jixiangyu

associate chief physician

The Affiliated Hospital of Qingdao University

研究点 (1)

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