Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy

Colonoscopy Clinical Trial

Official title:

Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy: a Single-center, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892928
• Other study ID #: 2019-12
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2023
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• 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. 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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the occurrence of hypotension	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	The time during gastroscopy, an average of 12 minutes
Secondary	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)	The time during gastroscopy, an average of 12 minutes
Secondary	The incidence of bradycardia	Bradycardia is defined as HR <50 beats/min	The time during gastroscopy, an average of 12 minutes
Secondary	The incidence of hypoxemia	Hypoxemia is defined as a decrease of SpO2 to <90%	The time during gastroscopy, an average of 12 minutes
Secondary	The incidence of mask-assisted ventilation	Mask ventilation is performed if the hypoxemia happened	The time during gastroscopy, an average of 12 minutes
Secondary	The incidence of body movement	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	The time during gastroscopy, an average of 12 minutes
Secondary	The discharge time	The discharge time is calculated from the end of colonoscopy to discharge	From the end of colonoscopy to discharge,an average of 30 minutes
Secondary	Patients satisfaction score	Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"	When the patient is fully awake after colonoscopy,an average of 5 minutes
Secondary	Endoscopists satisfaction score	Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"	At the end of colonoscopy