A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
研究概览
简要总结
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
- •Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour
排除标准
- •American Society of Anesthesiologists (ASA) grade III, IV V and VI
- •Baseline oxygen saturation<90% (room air)
- •Body Mass Index (BMI) >=35
研究组 & 干预措施
Arm 3 - ICI35,868 (propofol)
干预措施: ICI35,868 (propofol) (Drug)
Arm1 - Placebo
干预措施: Placebo (Drug)
Arm 2 - ICI35,868 (propofol)
干预措施: ICI35,868 (propofol) (Drug)
Arm 4 - ICI35,868 (propofol)
干预措施: ICI35,868 (propofol) (Drug)
Arm 5 - ICI35,868 (propofol)
干预措施: ICI35,868 (propofol) (Drug)
Arm 6 - ICI35,868 (propofol)
干预措施: ICI35,868 (propofol) (Drug)
Arm 7 - ICI35,868 (propofol)
干预措施: ICI35,868 (propofol) (Drug)
结局指标
主要结局
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
时间窗: 2 minutes from the beginning of the maintenance period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
时间窗: 4 minutes from the beginning of the maintenance period
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
次要结局
- Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire(24 - 48 hours after completion of the procedure)
- Blood Concentrations of Propofol(At the end of the initiation period and every 2 minutes during the maintenance period)
- Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period(Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7))