Effect of Low-dose Dexmedetomidine on Hypotension in Colonoscopy：a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- The primary outcome is the incidence of hypotension
研究概览
简要总结
104 patients who undergo painless colonoscopy from January 20,2024 to February 29,2024 will be randomized to two groups: propofol group and dexmedetomidine group.
In the dexmedetomidine group,dexmedetomidine is 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 is 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 January 20,2024 to February 29,2024 will be randomized to two groups: propofol group and dexmedetomidine group.
In the dexmedetomidine group,dexmedetomidine is 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 is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1.For all patients, if Ramsay sedation scale score reach 3, colonoscope will be inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg will be administrated as the rescue dose if body movement occur during colonoscopy.
The primary outcome is the occurrence of hypotension. Key secondary outcomes are time-weighted average (TWA), area under the threshold (AUT) and cumulative duration of hypotension, as well as the maximum reduction in BP. Other secondary outcomes include(1) the incidence of bradycardia, hypoxemia or body movement；(2) discharge time (from the end of colonoscopy to discharge); (3) patients and endoscopists' satisfaction score (using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"); (4) the incidence of dizziness, fatigue, or nausea and vomiting
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
- •renal impairment (glomerular filtration rate < 60 ml/min), significant hepatic impairment (ascites, cirrhosis, or with international normalized ratio(INR) >1.5)
研究组 & 干预措施
Dexmedetomidine group
Dexmedetomidine is 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 reach 3, colonoscope will be inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg will be administrated as the rescue dose if body movement occur during colonoscopy.
干预措施: Dexmedetomidine (Drug)
Propofol group
Propofol is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 until Ramsay score reach 3. During the whole process, propofol is given intermittently to maintain Ramsay score 3 to 4. If body movement happen, propofol 10mg will be administrated every time.
干预措施: Propofol (Drug)
结局指标
主要结局
The primary outcome is the incidence of hypotension
时间窗: The time during colonoscopy, an average of 15 minutes
Hypotension is defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP \< 90, and/or DBP \< 50 mmHg
次要结局
- Time-weighted average (TWA)(The time during colonoscopy, an average of 15 minutes)
- The incidence of hypoxemia(The time during colonoscopy, an average of 15 minutes)
- Maximum reduction in blood pressure (BP)(The time during colonoscopy, an average of 15 minutes)
- The incidence of bradycardia(The time during colonoscopy, an average of 15 minutes)
- Area under the threshold (AUT) of hypotension(The time during colonoscopy, an average of 15 minutes)
- Cumulative duration of hypotension(The time during colonoscopy, an average of 15 minutes)
- The body movement(The time during colonoscopy, an average of 15 minutes)
- Discharge time(From the end of colonoscopy to discharge，an average of 40 minutes)
- Patients satisfaction score(When the patient is fully awake after colonoscopy，an average of 5 minutes)
- Endoscopists'satisfaction score(At the end of colonoscopy,an average of 15 minutes)
- The incidence of dizziness(From the end of colonoscopy to discharge，an average of 40 minutes)
- The incidence of nausea and vomiting(From the end of colonoscopy to discharge，an average of 40 minutes)
- The incidence of fatigue(From the end of colonoscopy to discharge，an average of 40 minutes)
研究者
Chunling Jiang
Clinical Professor
West China Hospital