Clinical trial NCT03892928: Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy
Official title: Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy: a Single-center, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged above 18 years
2. American Society of Anesthesiologists (ASA) physical status of 1-2
3. Patients scheduled for sedation colonoscopy

Exclusion Criteria:

1. Emergency patients
2. Body weight \< 40 kg or \>100 kg
3. Allergy to dexmedetomidine, propofol in this trail, a previous adverse reaction to dexmedetomidine or propofol
4. Pregnancy or lactation
5. Drug abusers
6. Participation in other clinical studies within the previous 3 months

Primary outcomes:
measure: The primary outcome is the occurrence of hypotension
timeFrame: The time during gastroscopy, an average of 12 minutes
Secondary outcomes:
measure: The duration and the maximum decreasing in BP
timeFrame: The time during gastroscopy, an average of 12 minutes
measure: The incidence of bradycardia
timeFrame: The time during gastroscopy, an average of 12 minutes
measure: The incidence of hypoxemia
timeFrame: The time during gastroscopy, an average of 12 minutes
measure: The incidence of mask-assisted ventilation
timeFrame: The time during gastroscopy, an average of 12 minutes
measure: The incidence of body movement
timeFrame: The time during gastroscopy, an average of 12 minutes
measure: The discharge time
timeFrame: From the end of colonoscopy to discharge，an average of 30 minutes
measure: Patients satisfaction score
timeFrame: When the patient is fully awake after colonoscopy，an average of 5 minutes
measure: Endoscopists satisfaction score
timeFrame: At the end of colonoscopy
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: China, Sichuan West China Hospital
name: Chunling Jiang
role: STUDY_CHAIR
References: