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Completed

NCT Number: NCT03892928

Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.For all patients, 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

The primary outcome was the occurrence of hypotension. Secondary outcomes included the followings:(1) the duration and the maximum decreasing in BP. The time-weighted average which is measured by calculating the area under the threshold (AUT) divided by the total duration of colonoscopy. AUT = (depth of hypotension below a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline or SBP of 90 mm Hg or DBP of 50 mm Hg× time in minutes spent of hypotension); (2) the incidence of bradycardia and hypoxemia, mask-assisted ventilation and body movement;(3) the discharge time , patients and endoscopists satisfaction score.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Dexmedetomidine Hydrochloride group

Primary outcomes

  1. The primary outcome is the occurrence of hypotension

    Time frame: The time during gastroscopy, an average of 12 minutes

    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

Secondary outcomes

  1. The duration and the maximum decreasing in BP

    Time frame: The time during gastroscopy, an average of 12 minutes

    The time-weighted average which is measured by calculating the area under the threshold (AUT) divided by the total duration of colonoscopy. AUT = (depth of hypotension below a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline or SBP of 90 mm Hg or DBP of 50 mm Hg× time in minutes spent of hypotension)

  2. The incidence of bradycardia

    Time frame: The time during gastroscopy, an average of 12 minutes

    Bradycardia is defined as HR <50 beats/min

  3. The incidence of hypoxemia

    Time frame: The time during gastroscopy, an average of 12 minutes

    Hypoxemia is defined as a decrease of SpO2 to <90%

  4. The incidence of mask-assisted ventilation

    Time frame: The time during gastroscopy, an average of 12 minutes

    Mask ventilation is performed if the hypoxemia happened

  5. The incidence of body movement

    Time frame: The time during gastroscopy, an average of 12 minutes

    Body movement is defined as the twisting of the patient's body due to the stimulation of the endoscopy, making it difficult to proceed with the procedure without additional propofol

  6. The discharge time

    Time frame: From the end of colonoscopy to discharge,an average of 30 minutes

    The discharge time is calculated from the end of colonoscopy to discharge

  7. Patients satisfaction score

    Time frame: When the patient is fully awake after colonoscopy,an average of 5 minutes

    Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"

  8. Endoscopists satisfaction score

    Time frame: At the end of colonoscopy

    Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy: a Single-center, Randomized Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2019
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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