Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy

NCT03892928 | Completed

• 1 other identifier: 2019-12
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The duration and the maximum decreasing in BP

  The time during gastroscopy, an average of 12 minutes

• The incidence of bradycardia

  The time during gastroscopy, an average of 12 minutes

• The incidence of hypoxemia

  The time during gastroscopy, an average of 12 minutes

• The incidence of mask-assisted ventilation

  The time during gastroscopy, an average of 12 minutes

• The incidence of body movement

  The time during gastroscopy, an average of 12 minutes

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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.

Drug: Dexmedetomidine group

Propofol group

OTHER

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.

Drug: Dexmedetomidine group

Interventions

Dexmedetomidine group DRUG

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.

Also known as: Dexmedetomidine Hydrochloride group

Dexmedetomidine 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Study Officials

• Chunling Jiang

  China, Sichuan West China Hospital

  STUDY CHAIR

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: February 20, 2019
• First Posted: March 27, 2019
• Study Start: December 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

CN (1)