Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-07 @ 2:55 PM
Study NCT ID:
NCT06376760
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2024-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-04-13', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total consumption of intravenous anesthetic drug', 'timeFrame': 'Up to 1 day', 'description': 'The total consumption of intravenous anesthetic drug for digestive endoscopy. It includes the total amount of intravenous anesthesia drugs required by the patient for the entire process of digestive endoscopy.'}], 'secondaryOutcomes': [{'measure': 'The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope', 'timeFrame': '1 day', 'description': 'The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope'}, {'measure': 'The occurrence of the respiratory and cardiovascular adverse events', 'timeFrame': 'The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy', 'description': 'The occurrence of the respiratory and cardiovascular adverse events such as hypoxemia, hypotension, hypertension, arrhythmia'}, {'measure': 'The occurrence of the other adverse events', 'timeFrame': 'The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy', 'description': 'The occurrence of the other adverse events such as dizziness, agitation, nausea, vomiting and psychiatric symptom'}, {'measure': 'The incidence of intraoperative recall or awareness', 'timeFrame': 'The day for patients undergoing digestive endoscopy and 24 hours after the digestive endoscopy', 'description': 'The patient is conscious after anesthesia'}, {'measure': 'The recovery time', 'timeFrame': 'Up to 1 day', 'description': 'The time from when the patient stops intravenous anesthetic drug application to when they can open their eyes and nod their heads.'}, {'measure': "Duration of patients' PACU stay", 'timeFrame': 'Up to 1 day', 'description': "Patients' stay time in PACU"}, {'measure': 'The ease of operation at this level of sedation evaluated by the gastroenterologists', 'timeFrame': 'Up to 1 day', 'description': 'The ease of operation at this level of sedation (easy/medium/difficult) evaluated by the gastroenterologists'}, {'measure': 'The satisfaction degree of anesthesia effect evaluated by the gastroenterologists', 'timeFrame': 'Up to 1 day', 'description': 'The satisfaction degree of anesthesia effect (satisfactory/medium/unsatisfactory) evaluated by the gastroenterologists'}, {'measure': "Patients' satisfaction", 'timeFrame': 'Up to 1 day', 'description': "Patients' satisfaction with the procedure at this level of sedation (satisfactory/medium/unsatisfactory)"}, {'measure': "Patients' willingness", 'timeFrame': 'Up to 1 day', 'description': "Patients' willingness to undergo the next procedure at the same level of sedation"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digestive endoscopy', 'Insomnia', 'Intravenous anesthetic'], 'conditions': ['Insomnia', 'Digestive Endoscopy']}, 'descriptionModule': {'briefSummary': 'To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern.', 'detailedDescription': 'The investigators aim to investigate whether intravenous anesthetic drug dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with insomnia and patients with normal sleep patterns', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with insomnia:\n\n 1. Age of 18 - 64 years;\n 2. ASA physical status of I - II;\n 3. BMI of 15 - 30;\n 4. Scheduled for digestive endoscopy under intravenous anesthesia;\n 5. Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;\n 6. 8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less;\n* Patients with normal sleep:\n\n 1. Age of 18 - 64 years;\n 2. ASA physical status of I - II;\n 3. BMI of 15 - 30;\n 4. Scheduled for digestive endoscopy under intravenous anesthesia;\n 5. No history or evidence of insomnia.\n\nExclusion Criteria:\n\n* 1\\. Associated with any neurological disease; 2. Daily alcohol consumption; 3. Any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. History of allergy to any drug used in the study; 5. Pregnancy or breastfeeding; 6. Patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. Patients with psychological diseases who report suicidal thoughts; 9. Patients who need to work or take care of children/elderly people frequently at night.'}, 'identificationModule': {'nctId': 'NCT06376760', 'briefTitle': 'Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy: Study Protocol for a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'KY2024-091-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Insomnia group', 'description': 'Patients with insomnia', 'interventionNames': ['Other: No interventions, it is a observational study']}, {'label': 'Normal sleep group', 'description': 'Patients with normal sleep', 'interventionNames': ['Other: No interventions, it is a observational study']}], 'interventions': [{'name': 'No interventions, it is a observational study', 'type': 'OTHER', 'description': 'No interventions, this study is to compare the dosage requirement of intravenous anesthetic drug during digestive endoscopy between insomnia group and normal sleep group.', 'armGroupLabels': ['Insomnia group', 'Normal sleep group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Luo, M.D.', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '13611326978'}, {'name': 'Fang Luo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daxing Teaching Hospital, Capital Medical University', 'class': 'UNKNOWN'}, {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, {'name': "Hengshui People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Day surgery and Pain Management Affiliation: Beijing Tiantan Hospital', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}