NCT06857344招募中不适用
Automated Anesthesia System-Gastrointestinal Endoscopy (AAS-GE): a Reinforcement Learning Based Control for Anesthesia During Gastrointestinal Endoscopy
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.9 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2025年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 9
- 主要终点
- Incidence of hypoxemia
研究概览
简要总结
The goal of this clinical trial is to compare the performance difference between trained model and clinical professionals in anesthesia control during gastrointestinal endoscopy. The participants would include adults aged between 18-65 years old with ASA scores I-II. The main questions it aims to answer are:
- Can AI model successfully and safely perform anesthesia during gastrointestinal endoscopy?
- Researchers hypothesis that anesthesia performed by professionals is not inferior to those performed by AI model.
The researchers will compare the results of the AI group with the traditional group to see if both groups have similar success rates in performing anesthesia.
Participants will fast for 8 hours before the procedure, and drinking water will be prohibited for 2 hours after taking the intestinal purgatives.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status class I-II
- •Expected operation duration less than 1 hour
排除标准
- •History of cardiac, hepatic, renal, or metabolic disorders (e.g., diabetes, hypertension, sleep apnea)
- •Known allergy to opioids or ciprofloxacin components
- •Hypothermia; history of narcotic abuse; chronic alcoholism; obesity (BMI >30); patients with apnea
- •Current pregnancy or lactation
- •History of substance abuse or alcohol dependence
- •Participation in any other drug clinical trial within the past 3 months
- •Obesity (BMI >30 kg/m²)
- •Procedure termination due to gastric retention or inadequate bowel preparation
结局指标
主要结局
Incidence of hypoxemia
时间窗: During procedure
Hypoxemia is defined as blood oxygen saturation below 92% at any time.
次要结局
- Area under curve of hypoxemia(During procedure)
- Counts of body movement(During procedure)
- Duration of colonoscopy(During procedure)
- Ciprofol related adverse reactions(During procedure)
- Area under curve of hypoxemia(During procedure)
- Counts of body movement(During procedure)
- Dose of norepinephrine(During procedure)
- Duration of colonoscopy(During procedure)
- Ciprofol related adverse reactions(During procedure)
- Lowest value of blood oxygen saturation(During procedure)
- Induction and maintenance doses of anesthesia(During procedure)
- Induction time(During procedure)
- Complete recovery time(During procedure)
- Incidence of hypotension(During procedure)
研究者
研究点 (9)
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