ColonoscopyNCT03892928
Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy
A study testing Dexmedetomidine group in people with Colonoscopy, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Dexmedetomidine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged above 18 years
- American Society of Anesthesiologists (ASA) physical status of 1-2
- Patients scheduled for sedation colonoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy: a Single-center, Randomized 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 during the whole process.
Read the detailed description
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.
- Conditions
- Colonoscopy
- Being tested
- Dexmedetomidine group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine groupDrug
Also called Dexmedetomidine Hydrochloride 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The time during gastroscopy, an average of 12 minutes
Secondary outcomes (8)
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)
Measured: The time during gastroscopy, an average of 12 minutes
The incidence of bradycardia
Bradycardia is defined as HR <50 beats/min
Measured: The time during gastroscopy, an average of 12 minutes
The incidence of hypoxemia
Hypoxemia is defined as a decrease of SpO2 to <90%
Measured: The time during gastroscopy, an average of 12 minutes
The incidence of mask-assisted ventilation
Mask ventilation is performed if the hypoxemia happened
Measured: The time during gastroscopy, an average of 12 minutes
The incidence of body movement
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
Measured: The time during gastroscopy, an average of 12 minutes
The discharge time
The discharge time is calculated from the end of colonoscopy to discharge
Measured: From the end of colonoscopy to discharge，an average of 30 minutes
Patients satisfaction score
Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"
Measured: When the patient is fully awake after colonoscopy，an average of 5 minutes
Endoscopists satisfaction score
Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"
Measured: At the end of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Dec 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, Study chair, China, Sichuan West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892928
- Sponsor's protocol ID
- 2019-12
- Status last verified
- Sep 2023
- First submitted
- 20 Feb 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy: a Single-center, Randomized Study
- ClinicalTrials.gov ID
- NCT03892928
- Acronym / sponsor ID
- 2019-12
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine groupDexmedetomidine 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. |
| Propofol group | Other | Drug: Dexmedetomidine groupPropofol 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged above 18 years
- American Society of Anesthesiologists (ASA) physical status of 1-2
- Patients scheduled for sedation colonoscopy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine groupAlso: Dexmedetomidine Hydrochloride groupIn 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. | Drug | Dexmedetomidine group, Propofol group |
Primary outcome
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
8 secondary outcomes
The duration and the maximum decreasing in BP
Time frame: The time during gastroscopy, an average of 12 minutes
The incidence of bradycardia
Time frame: The time during gastroscopy, an average of 12 minutes
The incidence of hypoxemia
Time frame: The time during gastroscopy, an average of 12 minutes
The incidence of mask-assisted ventilation
Time frame: The time during gastroscopy, an average of 12 minutes
The incidence of body movement
Time frame: The time during gastroscopy, an average of 12 minutes
The discharge time
Time frame: From the end of colonoscopy to discharge，an average of 30 minutes
Patients satisfaction score
Time frame: When the patient is fully awake after colonoscopy，an average of 5 minutes
Endoscopists satisfaction score
Time frame: At the end of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunling Jiang study chair
China, Sichuan West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine group in people with Colonoscopy, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the occurrence of hypotension (time frame: The time during gastroscopy, an average of 12 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.