Effects and Mechanisms of Ambient Light Intensity on the Depth of General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The dose of sedative medications
研究概览
简要总结
The objective of this clinical trial is to investigate the effect of light exposure on sedation depth during general anesthesia.The primary research questions this study aims to address include:
Does light condition affect the dosage of anesthetic medications during anesthesia? By what mechanism does light exposure exert an influence on anesthesia? Participants will be randomly allocated to either the light-shielded group or the non-light-shielded group.Patients in the light-shielded group will wear an eye shield during anesthesia.
The following data will be recorded for all patients:
Induction drug dosage Induction time Intraoperative anesthetic dosage Emergence time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Data analyst
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Age between 18 and 65 years, regardless of gender;
- •b. ASA physical status I-II;
- •c. 18.5 ≤ BMI ≤ 28;
- •d. Signed written informed consent.
排除标准
- •a. Blindness or history of photosensitivity disorders;
- •b. Patients requiring medication for sleep, or with a history of sleep disorders;
- •c. Presence of neurological diseases;
- •d. Pregnancy;
- •e. Severe hepatic or renal dysfunction;
- •f. History of anesthetic drug abuse or alcohol abuse;
- •g. History of adverse anesthesia events (difficult airway, allergy to anesthetic agents).
研究组 & 干预措施
the non-light-shielded group
the light-shielded group
Patients in the light-shielded group will wear an opaque eye mask 30 minutes prior to induction of general anesthesia and continue to do so until the cessation of sedative medications for anesthesia.
干预措施: eye mask (Device)
结局指标
主要结局
The dose of sedative medications
时间窗: Perioperative
The dose of sedative medications required during the induction period in patients
次要结局
- Induction time of anesthesia(Perioperative)
- total dose of sedative medications(during surgery)
- emergence time(Perioperative)
研究者
Yi Feng, MD
Chief of Anesthesiology
Peking University People's Hospital