Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06208956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Low Dose Dexmedetomidine in Sedation Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is the incidence of hypotension', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Area under the threshold (AUT) of hypotension', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': '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.'}, {'measure': 'Time-weighted average (TWA)', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': 'TWA is calculated as the AUT divided by the total duration of colonoscopy'}, {'measure': 'Cumulative duration of hypotension', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': '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)'}, {'measure': 'Maximum reduction in blood pressure (BP)', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': 'Maximum reduction in systolic blood pressure (SBP) ,diastolic blood pressure (DBP) and mean arterial pressure (MAP) from baseline'}, {'measure': 'The incidence of bradycardia', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': 'Bradycardia is defined as heat rate(HR) \\<50 beats/min'}, {'measure': 'The incidence of hypoxemia', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': 'Hypoxemia is defined as oxygen saturation (SpO2)\\<90%'}, {'measure': 'The body movement', 'timeFrame': 'The time during colonoscopy, an average of 15 minutes', 'description': "The twisting of the patient's body due to the stimulation of the colonoscopy, making it difficult to proceed with the procedure"}, {'measure': 'Discharge time', 'timeFrame': 'From the end of colonoscopy to discharge，an average of 40 minutes', 'description': 'From the end of colonoscopy to discharge'}, {'measure': 'Patients satisfaction score', 'timeFrame': 'When the patient is fully awake after colonoscopy，an average of 5 minutes', 'description': 'Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"'}, {'measure': "Endoscopists'satisfaction score", 'timeFrame': 'At the end of colonoscopy,an average of 15 minutes', 'description': 'Using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"'}, {'measure': 'The incidence of dizziness', 'timeFrame': 'From the end of colonoscopy to discharge，an average of 40 minutes', 'description': 'The investigators consider it dizziness if patients fell any dizziness'}, {'measure': 'The incidence of fatigue', 'timeFrame': 'From the end of colonoscopy to discharge，an average of 40 minutes', 'description': 'The investigators consider it fatigue if patients fell any fatigue'}, {'measure': 'The incidence of nausea and vomiting', 'timeFrame': 'From the end of colonoscopy to discharge，an average of 40 minutes', 'description': 'The investigators consider it nausea and vomiting if patients fell any nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.', 'detailedDescription': '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.\n\nIn 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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged above 18 years\n2. American Society of Anesthesiologists (ASA) physical status of 1-2\n3. Patients scheduled for sedation colonoscopy\n\nExclusion Criteria:\n\n1. Emergency patients\n2. Body weight \\< 40 kg or \\>100 kg\n3. Allergy to dexmedetomidine, propofol in this trail, a previous adverse reaction to dexmedetomidine or propofol\n4. Pregnancy or lactation\n5. Drug abusers\n6. Participation in other clinical studies within the previous 3 months\n7. renal impairment (glomerular filtration rate \\< 60 ml/min), significant hepatic impairment (ascites, cirrhosis, or with international normalized ratio(INR) \\>1.5)'}, 'identificationModule': {'nctId': 'NCT06208956', 'briefTitle': 'A Low Dose Dexmedetomidine in Sedation Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Effect of Low-dose Dexmedetomidine on Hypotension in Colonoscopy：a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-2105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': '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.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'OTHER', 'label': 'Propofol group', 'description': '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.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine group'], 'description': '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.', 'armGroupLabels': ['Dexmedetomidine group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol group'], 'description': '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.', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li Zhou', 'role': 'CONTACT', 'email': 'zlmz@wchscu.cn', 'phone': '18980606160'}, {'name': 'Mao Ye', 'role': 'CONTACT', 'email': '838915882@qq.com', 'phone': '13540432883'}], 'overallOfficials': [{'name': 'Li Zhou', 'role': 'STUDY_CHAIR', 'affiliation': 'China, Sichuan West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Chunling Jiang', 'investigatorAffiliation': 'West China Hospital'}}}}