ColonoscopyNCT06208956
A Low Dose Dexmedetomidine in Sedation Colonoscopy
A study testing Dexmedetomidine and Propofol in people with Colonoscopy, run by West China Hospital.
Trial 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… 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 and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2024to 29 Feb 2024
- 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
- renal impairment (glomerular filtration rate < 60 ml/min), significant hepatic impairment (ascites, cirrhosis, or with international normalized ratio(INR) >1.5)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Low-dose Dexmedetomidine on Hypotension in Colonoscopy：a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Dexmedetomidine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called 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. 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.
PropofolDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The time during colonoscopy, an average of 15 minutes
Secondary outcomes (13)
Area under the threshold (AUT) of hypotension
AUT=depth of hypotension below (a 20% decrease in baseline SBP or DBP) or (90 mm Hg of SBP or 50 mm Hg of DBP)× time in minutes spent of hypotension. As an example, a patient undergoes colonoscopy that lasts 15 min, in which he experiences 2 episodes of hypotension, all lasting for 1 min and all with a minimal SBP of 80 mm Hg. The AUT = 2 min × (90 -80= 10 mm Hg under the SBP threshold of 90 mm Hg) = 2×10 = 20 mm Hg per minute.
Measured: The time during colonoscopy, an average of 15 minutes
Time-weighted average (TWA)
TWA is calculated as the AUT divided by the total duration of colonoscopy
Measured: The time during colonoscopy, an average of 15 minutes
Cumulative duration of hypotension
The total time of patients experience hypotenion（hpotension defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP < 90, and/or DBP < 50 mmHg)
Measured: The time during colonoscopy, an average of 15 minutes
Maximum reduction in blood pressure (BP)
Maximum reduction in systolic blood pressure (SBP) ,diastolic blood pressure (DBP) and mean arterial pressure (MAP) from baseline
Measured: The time during colonoscopy, an average of 15 minutes
The incidence of bradycardia
Bradycardia is defined as heat rate(HR) <50 beats/min
Measured: The time during colonoscopy, an average of 15 minutes
The incidence of hypoxemia
Hypoxemia is defined as oxygen saturation (SpO2)<90%
Measured: The time during colonoscopy, an average of 15 minutes
The body movement
The twisting of the patient's body due to the stimulation of the colonoscopy, making it difficult to proceed with the procedure
Measured: The time during colonoscopy, an average of 15 minutes
Discharge time
From the end of colonoscopy to discharge
Measured: From the end of colonoscopy to discharge，an average of 40 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,an average of 15 minutes
The incidence of dizziness
The investigators consider it dizziness if patients fell any dizziness
Measured: From the end of colonoscopy to discharge，an average of 40 minutes
The incidence of fatigue
The investigators consider it fatigue if patients fell any fatigue
Measured: From the end of colonoscopy to discharge，an average of 40 minutes
The incidence of nausea and vomiting
The investigators consider it nausea and vomiting if patients fell any nausea and vomiting
Measured: From the end of colonoscopy to discharge，an average of 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Li Zhou, Study chair, China, Sichuan West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208956
- Sponsor's protocol ID
- 2023-2105
- Status last verified
- Jan 2024
- First submitted
- 11 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Dexmedetomidine on Hypotension in Colonoscopy：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06208956
- Acronym / sponsor ID
- 2023-2105
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 17 Jan 2024 (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 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
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: DexmedetomidineDexmedetomidine 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. |
| Propofol group | Other | Drug: PropofolPropofol 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. |
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 (7 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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine groupIn 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. | Drug | Dexmedetomidine group |
| PropofolAlso: Propofol groupPropofol 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 group |
Primary outcome
The primary outcome is the incidence of hypotension
Time frame: The time during colonoscopy, an average of 15 minutes
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
13 secondary outcomes
Area under the threshold (AUT) of hypotension
Time frame: The time during colonoscopy, an average of 15 minutes
Time-weighted average (TWA)
Time frame: The time during colonoscopy, an average of 15 minutes
Cumulative duration of hypotension
Time frame: The time during colonoscopy, an average of 15 minutes
Maximum reduction in blood pressure (BP)
Time frame: The time during colonoscopy, an average of 15 minutes
The incidence of bradycardia
Time frame: The time during colonoscopy, an average of 15 minutes
The incidence of hypoxemia
Time frame: The time during colonoscopy, an average of 15 minutes
The body movement
Time frame: The time during colonoscopy, an average of 15 minutes
Discharge time
Time frame: From the end of colonoscopy to discharge，an average of 40 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,an average of 15 minutes
The incidence of dizziness
Time frame: From the end of colonoscopy to discharge，an average of 40 minutes
The incidence of fatigue
Time frame: From the end of colonoscopy to discharge，an average of 40 minutes
The incidence of nausea and vomiting
Time frame: From the end of colonoscopy to discharge，an average of 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Li Zhou study chair
China, Sichuan West China Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Propofol in people with Colonoscopy, run by West China Hospital.
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 7 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhou (18980606160, zlmz@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the incidence of hypotension (time frame: The time during colonoscopy, an average of 15 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 17 Jan 2024.