NCT06208956

A Low Dose Dexmedetomidine in Sedation Colonoscopy

Effect of Low-dose Dexmedetomidine on Hypotension in Colonoscopy：a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	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. 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.
DRUG	Propofol	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.

Timeline

• Start date: 2024-01-20
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2024-01-17
• Last updated: 2024-01-17