A Low Dose Dexmedetomidine in Sedation Colonoscopy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol

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

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Zhou; Phone Number: 18980606160; Email: zlmz@wchscu.cn
• Study Contact Backup: Name: Mao Ye; Phone Number: 13540432883; Email: 838915882@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. 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.	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.; Other Names: Dexmedetomidine group
Other: Propofol group; 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.	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.; Other Names: Propofol group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
The incidence of bradycardia	Bradycardia is defined as heat rate(HR) <50 beats/min	The time during colonoscopy, an average of 15 minutes
The incidence of hypoxemia	Hypoxemia is defined as oxygen saturation (SpO2)<90%	The time during colonoscopy, an average of 15 minutes
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
Discharge time	From the end of colonoscopy to discharge	From the end of colonoscopy to discharge，an average of 40 minutes
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
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
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Chair: Li Zhou, China, Sichuan West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2024
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 2023-2105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No