A Low Dose Dexmedetomidine in Sedation Colonoscopy

NCT06208956 | Unknown DMC

• 1 other identifier: 2023-2105
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Area under the threshold (AUT) of hypotension

  The time during colonoscopy, an average of 15 minutes

• Time-weighted average (TWA)

  The time during colonoscopy, an average of 15 minutes

• Cumulative duration of hypotension

  The time during colonoscopy, an average of 15 minutes

• Maximum reduction in blood pressure (BP)

  The time during colonoscopy, an average of 15 minutes

• The incidence of bradycardia

  The time during colonoscopy, an average of 15 minutes

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Propofol group

OTHER

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

Interventions

Dexmedetomidine 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.

Also known as: Dexmedetomidine group

Dexmedetomidine group

Propofol 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.

Also known as: Propofol group

Propofol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged above 18 years
• American Society of Anesthesiologists (ASA) physical status of 1-2
• Patients scheduled for sedation colonoscopy

You may not qualify if:

• Emergency patients
• Body weight \< 40 kg or \>100 kg
• Allergy to dexmedetomidine, propofol in this trail, a previous adverse reaction to dexmedetomidine or propofol
• Pregnancy or lactation
• Drug abusers
• Participation in other clinical studies within the previous 3 months
• renal impairment (glomerular filtration rate \< 60 ml/min), significant hepatic impairment (ascites, cirrhosis, or with international normalized ratio(INR) \>1.5)

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Li Zhou

  China, Sichuan West China Hospital

  STUDY CHAIR

Central Study Contacts

Li Zhou

CONTACT

18980606160; zlmz@wchscu.cn

Mao Ye

CONTACT

13540432883; 838915882@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 17, 2024
• Study Start: January 20, 2024
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share