Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Cough
研究概览
简要总结
This is a prospective clinical study to compare the anesthetic effect of remimazolam combined with remifentanil administered at different time points during gastroscope insertion in patients undergoing painless gastroscopy.The primary outcomes include sedation effect, intraoperative hemodynamic stability, recovery time, and adverse events.
详细描述
This study hypothesized that a dual criterion (absent jaw reflex and stable heart rate) for guiding endoscope insertion is superior to the single eyelash reflex criterion in painless gastroscopy with remimazolam and remifentanil. A short delay after heart rate stabilization may achieve the best balance of safety and efficacy. This randomized controlled trial aims to verify the dual criterion, determine the optimal insertion time window, and establish a standardized clinical protocol.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, anesthesiologists performing the procedure, and outcome assessors are blinded to group allocation.Group assignment is concealed using a random number table or central randomization system.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status Ⅰ/Ⅱ, BMI 18-24kg/m², scheduled for elective diagnostic painless gastroscopy
排除标准
- •(1) Allergy to remimazolam, remifentanil, BZDs, or opioids; (2) Difficult airway (Mallampati class Ⅲ/Ⅳ,limited mandibular movement, or restricted neck extension);(3)Severe cardiovascular/cerebrovascular/respiratory/hepatic/renal dysfunction;(4)Pregnancy/lactation;(5)Chronic use of sedatives/analgesics/psychotropic drugs; (6) Preoperative pulmonary infection/respiratory failure; (7) Inability to provide informed consent or complete follow-up.
研究组 & 干预措施
G group
The timing point for gastroscope insertion was defined as when the patient's mandible was lifted, no motor response was observed any longer, and the h
干预措施: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion (Other)
C group
The timing point for gastroscope insertion was determined when the corneal reflex was absent.
干预措施: Eyelash reflex guided endoscope insertionn (Other)
结局指标
主要结局
Cough
时间窗: From start of endoscope insertion until completion of gastroscopy
Incidence of coughing during endoscope insertion and examination
Body movement
时间窗: From start of endoscope insertion until completion of gastroscopy
Incidence of body movement
Hypotension
时间窗: From start of endoscope insertion until completion of gastroscopy
Incidence of hypotension
Bradycardia
时间窗: From start of endoscope insertion until completion of gastroscopy
Incidence of bradycardia
Hypoxemia
时间窗: From start of endoscope insertion until completion of gastroscopy
Incidence of hypoxemia
次要结局
- Endoscopist satisfaction score(Immediately after completion of gastroscopy)
- PACU discharge time(From admission to PACU until discharge from PACU)
研究者
Jianhao Zeng
Anesthesiology Resident
Huizhou First People's Hospital