Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy: a Single-center, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The primary outcome is the occurrence of hypotension
研究概览
简要总结
104 patients who undergo painless colonoscopy from Decemenber 1,2019 to June 30,2022 will be randomized to two groups: propofol group and dexmedetomidine group.
In the dexmedetomidine group,dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 during the whole process.
详细描述
104 patients who undergo painless colonoscopy from Decemenber 1,2019 to June 30,2022 will be randomized to two groups: propofol group and dexmedetomidine group.
In the dexmedetomidine group,dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1.For all patients, if Ramsay sedation scale score reached 3, colonoscope was inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg was administrated as the rescue dose if body movement occurred during colonoscopy
The primary outcome was the occurrence of hypotension. Secondary outcomes included the followings:(1) the duration and the maximum decreasing in BP. The time-weighted average which is measured by calculating the area under the threshold (AUT) divided by the total duration of colonoscopy. AUT = (depth of hypotension below a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline or SBP of 90 mm Hg or DBP of 50 mm Hg× time in minutes spent of hypotension); (2) the incidence of bradycardia and hypoxemia, mask-assisted ventilation and body movement；(3) the discharge time , patients and endoscopists satisfaction score.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 18 years
- •American Society of Anesthesiologists (ASA) physical status of 1-2
- •Patients scheduled for sedation colonoscopy
排除标准
- •Emergency patients
- •Body weight < 40 kg or >100 kg
- •Allergy to dexmedetomidine, propofol in this trail, a previous adverse reaction to dexmedetomidine or propofol
- •Pregnancy or lactation
- •Drug abusers
- •Participation in other clinical studies within the previous 3 months
研究组 & 干预措施
Dexmedetomidine group
Dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. If Ramsay sedation scale score reached 3, colonoscope was inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg was administrated as the rescue dose if body movement occurred during colonoscopy.
干预措施: Dexmedetomidine group (Drug)
Propofol group
Propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 until Ramsay score reached 3. During the whole process, propofol was given intermittently to maintain Ramsay score 3 to 4. If body movement happened, propofol 10mg was administrated every time.
干预措施: Dexmedetomidine group (Drug)
结局指标
主要结局
The primary outcome is the occurrence of hypotension
时间窗: The time during gastroscopy, an average of 12 minutes
Hypotension is defined as a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline, systolic blood pressure \< 90 mmHg, and/or diastolic blood pressure \< 50 mmHg
次要结局
- Patients satisfaction score(When the patient is fully awake after colonoscopy，an average of 5 minutes)
- Endoscopists satisfaction score(At the end of colonoscopy)
- The incidence of hypoxemia(The time during gastroscopy, an average of 12 minutes)
- The duration and the maximum decreasing in BP(The time during gastroscopy, an average of 12 minutes)
- The incidence of mask-assisted ventilation(The time during gastroscopy, an average of 12 minutes)
- The discharge time(From the end of colonoscopy to discharge，an average of 30 minutes)
- The incidence of bradycardia(The time during gastroscopy, an average of 12 minutes)
- The incidence of body movement(The time during gastroscopy, an average of 12 minutes)
研究者
Chunling Jiang
Clinical Professor
West China Hospital