West China Hospital
Chengdu, Sichuan, 610041, China
NCT Number: NCT03892928
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.
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All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610041, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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. 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. In the 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.
Other names: Dexmedetomidine Hydrochloride group
Time frame: 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
Time frame: The time during gastroscopy, an average of 12 minutes
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)
Time frame: The time during gastroscopy, an average of 12 minutes
Bradycardia is defined as HR <50 beats/min
Time frame: The time during gastroscopy, an average of 12 minutes
Hypoxemia is defined as a decrease of SpO2 to <90%
Time frame: The time during gastroscopy, an average of 12 minutes
Mask ventilation is performed if the hypoxemia happened
Time frame: The time during gastroscopy, an average of 12 minutes
Body movement is defined as the twisting of the patient's body due to the stimulation of the endoscopy, making it difficult to proceed with the procedure without additional propofol
Time frame: From the end of colonoscopy to discharge,an average of 30 minutes
The discharge time is calculated from the end of colonoscopy to discharge
Time frame: When the patient is fully awake after colonoscopy,an average of 5 minutes
Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"
Time frame: At the end of colonoscopy
Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"
West China Hospital
Other
Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy: a Single-center, Randomized Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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