A Low Dose Dexmedetomidine in Sedation Colonoscopy

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208956
• Other study ID #: 2023-2105
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2024
• Source: West China Hospital
• Contact: Li Zhou
• Phone: 18980606160
• Email: zlmz[@]wchscu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• 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

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the incidence of hypotension	Hypotension is defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP < 90, and/or DBP < 50 mmHg	The time during colonoscopy, an average of 15 minutes
Secondary	Area under the threshold (AUT) of hypotension	AUT=depth of hypotension below (a 20% decrease in baseline SBP or DBP) or (90 mm Hg of SBP or 50 mm Hg of DBP)× time in minutes spent of hypotension. As an example, a patient undergoes colonoscopy that lasts 15 min, in which he experiences 2 episodes of hypotension, all lasting for 1 min and all with a minimal SBP of 80 mm Hg. The AUT = 2 min × (90 -80= 10 mm Hg under the SBP threshold of 90 mm Hg) = 2×10 = 20 mm Hg per minute.	The time during colonoscopy, an average of 15 minutes
Secondary	Time-weighted average (TWA)	TWA is calculated as the AUT divided by the total duration of colonoscopy	The time during colonoscopy, an average of 15 minutes
Secondary	Cumulative duration of hypotension	The total time of patients experience hypotenion(hpotension defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP < 90, and/or DBP < 50 mmHg)	The time during colonoscopy, an average of 15 minutes
Secondary	Maximum reduction in blood pressure (BP)	Maximum reduction in systolic blood pressure (SBP) ,diastolic blood pressure (DBP) and mean arterial pressure (MAP) from baseline	The time during colonoscopy, an average of 15 minutes
Secondary	The incidence of bradycardia	Bradycardia is defined as heat rate(HR) <50 beats/min	The time during colonoscopy, an average of 15 minutes
Secondary	The incidence of hypoxemia	Hypoxemia is defined as oxygen saturation (SpO2)<90%	The time during colonoscopy, an average of 15 minutes
Secondary	The body movement	The twisting of the patient's body due to the stimulation of the colonoscopy, making it difficult to proceed with the procedure	The time during colonoscopy, an average of 15 minutes
Secondary	Discharge time	From the end of colonoscopy to discharge	From the end of colonoscopy to discharge,an average of 40 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,an average of 15 minutes
Secondary	The incidence of dizziness	The investigators consider it dizziness if patients fell any dizziness	From the end of colonoscopy to discharge,an average of 40 minutes
Secondary	The incidence of fatigue	The investigators consider it fatigue if patients fell any fatigue	From the end of colonoscopy to discharge,an average of 40 minutes
Secondary	The incidence of nausea and vomiting	The investigators consider it nausea and vomiting if patients fell any nausea and vomiting	From the end of colonoscopy to discharge,an average of 40 minutes