A Low Dose Dexmedetomidine in Sedation Colonoscopy

NCT ID: NCT06208956

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2024-02-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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 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.

Group Type: OTHER

Propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine group; Propofol group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chunling Jiang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Zhou

Role: STUDY_CHAIR

China, Sichuan West China Hospital

Central Contacts

Li Zhou

Role: CONTACT

zlmz@wchscu.cn

18980606160

Mao Ye

Role: CONTACT

838915882@qq.com

13540432883

Other Identifiers

2023-2105

Identifier Type: -

Identifier Source: org_study_id