Clinical trial NCT06208956: A Low Dose Dexmedetomidine in Sedation Colonoscopy
Official title: Effect of Low-dose Dexmedetomidine on Hypotension in Colonoscopy：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonoscopy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-01-17
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 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.

Detailed description: 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

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
7. renal impairment (glomerular filtration rate \< 60 ml/min), significant hepatic impairment (ascites, cirrhosis, or with international normalized ratio(INR) \>1.5)

Primary outcomes:
measure: The primary outcome is the incidence of hypotension
timeFrame: The time during colonoscopy, an average of 15 minutes
Secondary outcomes:
measure: Area under the threshold (AUT) of hypotension
timeFrame: The time during colonoscopy, an average of 15 minutes
measure: Time-weighted average (TWA)
timeFrame: The time during colonoscopy, an average of 15 minutes
measure: Cumulative duration of hypotension
timeFrame: The time during colonoscopy, an average of 15 minutes
measure: Maximum reduction in blood pressure (BP)
timeFrame: The time during colonoscopy, an average of 15 minutes
measure: The incidence of bradycardia
timeFrame: The time during colonoscopy, an average of 15 minutes
measure: The incidence of hypoxemia
timeFrame: The time during colonoscopy, an average of 15 minutes
measure: The body movement
timeFrame: The time during colonoscopy, an average of 15 minutes
measure: Discharge time
timeFrame: From the end of colonoscopy to discharge，an average of 40 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,an average of 15 minutes
measure: The incidence of dizziness
timeFrame: From the end of colonoscopy to discharge，an average of 40 minutes
measure: The incidence of fatigue
timeFrame: From the end of colonoscopy to discharge，an average of 40 minutes
measure: The incidence of nausea and vomiting
timeFrame: From the end of colonoscopy to discharge，an average of 40 minutes
Other outcomes:
Locations:
Study officials:
affiliation: China, Sichuan West China Hospital
name: Li Zhou
role: STUDY_CHAIR
References: