Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Dexmedetomidine group

• Registration Number: NCT03892928
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-12-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	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.
Propofol group	Dexmedetomidine 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.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the occurrence of hypotension	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

Secondary Outcome Measures

Name	Time	Method
Patients satisfaction score	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"
Endoscopists satisfaction score	At the end of colonoscopy	Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"
The incidence of hypoxemia	The time during gastroscopy, an average of 12 minutes	Hypoxemia is defined as a decrease of SpO2 to \<90%
The duration and the maximum decreasing in BP	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)
The incidence of mask-assisted ventilation	The time during gastroscopy, an average of 12 minutes	Mask ventilation is performed if the hypoxemia happened
The discharge time	From the end of colonoscopy to discharge，an average of 30 minutes	The discharge time is calculated from the end of colonoscopy to discharge
The incidence of bradycardia	The time during gastroscopy, an average of 12 minutes	Bradycardia is defined as HR \<50 beats/min
The incidence of body movement	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

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China