Effect of Bispectral Index Monitoring and Observer's Assessment Alert Sedation Scale (OAA/S) Guided Sedation on Body Movement of Outpatients Undergoing Gastroscopy: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The primary outcome is the incidence of moderate to severe body movement during gastroscopy
研究概览
简要总结
Patients who meet the enrollment criteria were randomized 1:1 to either the BIS group or the OAA/S group.
In the BIS group, the anesthesiologist set the target controlled infusion（TCI）parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5 ug/ml, and the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the BIS value at 45-60. In the OAA/S group, the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the OAA/S value at 1 point.
详细描述
Patients who meet the enrollment criteria were randomized 1:1 to either the BIS group or the OAA/S group.
In the BIS group, the anesthesiologist set the target controlled infusion (TCI) parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5 ug/ml, and the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the BIS value at 45-60. In the OAA/S group, the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the OAA/S value at 1 point.
Body movement, the time of gastroscopy, endoscopist satisfaction scores to sedation, the propofol consumption during gastroscopy and the time to awake were be recorded. In addition, the event of the respiration and circulation suppression during the gastroscopy were recorded. Atropine 0.3 mg was injected intravenously if bradycardia occurred (heart rate <50 beats/min), M-hydroxyamine 0.3 mg was injected intravenously if hypotension (mean arterial pressure<65 mmHg), Ephedrine 3 mg was injected if bradycardia and hypotension occured. Patients would receive face mask-assisted ventilation if the Spo2 dropped below 90% or respiratory frequency was lower than 8 breaths/min during the gastroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •18≤Age≤65 years old
- •American Society of Anaesthesiologists (ASA) Physical Status of I - II
- •18≤BMI≤30 kg/m²
- •Outpatient patients who planned to undergo painless gastroscopy under propofol anesthesia
排除标准
- •Patients with communication disorders
- •Patients with alcohol and drug abuse or allergic or contraindicated drugs related to this trail
- •Patients who take anti-anxiety, depression or sedative drugs
- •Patients who participated in or were participating in other clinical trials within 3 months
研究组 & 干预措施
BIS group
In the BIS group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ml every two minutes to maintain the BIS value at 45-60.
干预措施: Bispectral index (Other)
BIS group
In the BIS group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ml every two minutes to maintain the BIS value at 45-60.
干预措施: Gastroscopy (Procedure)
BIS group
In the BIS group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ml every two minutes to maintain the BIS value at 45-60.
干预措施: Propofol (Drug)
OAAS/S group
In the OAAS/S group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ml every two minutes maintain the OAA/S value at 1 point.
干预措施: Observer's assessment alert Sedation (Other)
OAAS/S group
In the OAAS/S group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ml every two minutes maintain the OAA/S value at 1 point.
干预措施: Gastroscopy (Procedure)
OAAS/S group
In the OAAS/S group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ml every two minutes maintain the OAA/S value at 1 point.
干预措施: Propofol (Drug)
结局指标
主要结局
The primary outcome is the incidence of moderate to severe body movement during gastroscopy
时间窗: The time during gastroscopy, an average of 15 minutes
Moderate to severe body movement is defined as the twisting of the patient's body due to the stimulation of the gastroscopy, making it difficult to proceed with the procedure without additional propofol.
次要结局
- The time of gastroscopy(The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes)
- The incidence of bradycardia(The time during gastroscopy，an average of 15 minutes)
- The incidence of hypoxemia(The time during gastroscopy，an average of 15 minutes)
- Endoscopist satisfaction scores(At the end of the gastroscopy)
- The incidence of hypotension(The time during gastroscopy, an average of 15 minutes)
- The propofol consumption during gastroscopy(From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes)
- The time to awake(The time from the end of gastroscopy to the observer's assessment alert sedation equal to 5, up to 30 minutes)
研究者
Chunling Jiang
Professor
West China Hospital