Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-04-14 @ 10:46 AM
Study NCT ID:
NCT05643066
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esketamine-propofol Versus Propofol for Flexible Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportions of patients discharged within 30 min after bronchoscopy', 'timeFrame': 'Up to 40 minutes postoperatively', 'description': 'Discharge readiness will be measured using the Modified Post Anesthetic Discharge Scoring System scale (greater than or equal to nine).'}], 'secondaryOutcomes': [{'measure': 'Postoperative quality of recovery', 'timeFrame': 'Baseline, up to 72 hours postoperatively', 'description': 'Postoperative quality of recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a digital measurement tool to quantify physiological, emotive, nociceptive, activities of daily living, and cognitive domain of postoperative recovery over time. Recovery in various domains of the PostopQRS is defined by postoperative values equaling or exceeding individual baseline values.'}, {'measure': 'Injection pain', 'timeFrame': 'Immediately after administering the study drugs, on average 2 minutes', 'description': 'Injection pain was assessed using a numeric rating scale of 0 to 10 (0 equals no pain, and 10 equals the worst pain imaginable).'}, {'measure': 'Emergency time', 'timeFrame': 'Immediately after the bronchoscopy completely withdrawn, on average 8 minutes', 'description': 'Emergency time was defined as the interval from the end of bronchoscopy to the MOAA/S score equal to five.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 72 h postoperatively', 'description': 'Episodes of adverse events such as bradycardia, tachycardia, hypotension, hypertension, hypoxia, nausea, vomiting, nightmare, and blurred vision'}, {'measure': 'Propofol consumption', 'timeFrame': 'During the bronchoscopy procedure', 'description': 'Propofol consumption will be recorded during the bronchoscopy procedure.'}, {'measure': 'Patient willingness to repeat the procedure', 'timeFrame': '24 hours postoperatively', 'description': 'Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure).'}, {'measure': 'Bronchoscopist satisfaction', 'timeFrame': 'At completion of bronchoscopy procedure', 'description': 'Bronchoscopist satisfaction will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At completion of bronchoscopy procedure', 'description': 'Bronchoscopist satisfaction will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).'}, {'measure': 'Patient willingness to recommend screening', 'timeFrame': '24 hours postoperatively', 'description': 'Patients will be asked whether they would recommend bronchoscopy screening to a friend or a relative (Yes/No/Unsure).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchoscopy', 'esketamine', 'procedure sedation', 'propofol'], 'conditions': ['Postoperative Recovery']}, 'descriptionModule': {'briefSummary': 'Bronchoscopy is a promising technology for lung and bronchus disease detection and therapy. However, this procedure is associated with a relatively high risk of hypoxemia, coughing, wheezing, and dyspnea. Despite the fact that propofol is the most commonly used agent in procedure sedation, the narrow therapeutic index remains challenging. Esketamine is the s-enantiomer of ketamine with potent analgesic and sedative properties. This study aims to test the hypothesis that adding subanesthetic esketamine to propofol is non-inferior to propofol alone for bronchoscopy on the recovery profile and discharge from the hospital.', 'detailedDescription': 'Bronchoscopy is one of the most common procedures to detect lung and bronchus disease. The procedure is generally uncomfortable and associated with a relatively high risk of hypoxemia, coughing, wheezing, and dyspnea. Therefore, physicians are placing increasing importance on the use of procedure sedation due to the demand for comfortable medical care.\n\nPropofol is an effective agent for sedation in bronchoscopy with rapid onset and recovery. However, the safety endpoints of propofol are not cost-effective, including injection pain, hypotension, apnea, airway compromise, and without a reversal agent. Specifically, the depressive effects on the respiratory system are more noteworthy in bronchoscopy, which may lead to hypoxia. These drawbacks may hinder functional recovery and delay the discharge time. Hence, physicians are searching for an optimal sedation regimen for bronchoscopy.\n\nEsketamine, the s-enantiomer of ketamine, is an N-methyl-D-aspartic acid receptor antagonist with potent analgesic and sedative properties. Evidence suggested that esketamine could be used as a component of sedative regimen in many settings, such as endoscopy and endoscopic retrograde cholangiopancreatography. Nevertheless, there remains an evidence gap in the efficacy and safety of esketamine used in bronchoscopy. Therefore, we conducted this study to test the hypothesis that low-dose esketamine as an adjuvant to propofol was non-inferior to propofol alone on the recovery profile and discharge from the hospital after ambulatory bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) classification I-III;\n2. Scheduled for ambulatory bronchoscopy.\n\nExclusion Criteria:\n\n1. Allergic or contraindications to studying drugs\n2. History of obstructive sleep apnea-hypopnea syndrome\n3. History of psychiatric illness\n4. History of neurological disease\n5. Pre-existing memory or cognitive impairment\n6. History of seizure disorders\n7. Pregnancy\n8. Substance abuse or intake of drugs that affect the central nervous system\n9. Inability to communicate in Mandarin Chinese.\n10. Illiteracy'}, 'identificationModule': {'nctId': 'NCT05643066', 'briefTitle': 'Esketamine-propofol Versus Propofol for Flexible Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Discharge Readiness After Propofol With or Without Esketamine for Outpatient Flexible Bronchoscopy: a Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'K2021-12-067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.1 mg/kg esketamine group', 'description': 'Procedure sedation was induced using intravenous 0.1 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).', 'interventionNames': ['Drug: 0.1 mg/kg esketamine', 'Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': '0.2 mg/kg esketamine group', 'description': 'Procedure sedation was induced using intravenous 0.2 mg/kg esketamine and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).', 'interventionNames': ['Drug: 0.2 mg/kg esketamine', 'Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Procedure sedation was induced using intravenous 0.9% saline and propofol 1 mg/kg. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).', 'interventionNames': ['Drug: 0.9% saline', 'Drug: Propofol']}], 'interventions': [{'name': '0.1 mg/kg esketamine', 'type': 'DRUG', 'otherNames': ['S-ketamine 0.1 mg/kg'], 'description': 'Esketamine 0.1 mg/kg was intravenously injected first.', 'armGroupLabels': ['0.1 mg/kg esketamine group']}, {'name': '0.2 mg/kg esketamine', 'type': 'DRUG', 'otherNames': ['S-ketamine 0.2 mg/kg'], 'description': 'Esketamine 0.2 mg/kg was intravenously injected first.', 'armGroupLabels': ['0.2 mg/kg esketamine group']}, {'name': '0.9% saline', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': '0.9% saline was intravenously injected first.', 'armGroupLabels': ['Placebo group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['propofol injection'], 'description': 'Propofol 1 mg/kg was injected immediately. Afterward, propofol 0.5 mg/kg was administered to maintain the target sedation level (MOAA/S of less than three).', 'armGroupLabels': ['0.1 mg/kg esketamine group', '0.2 mg/kg esketamine group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian provincial hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Xiaochun Zheng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fujian Provincial Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'We would like to share our individual deidentified participant data beginning three months following the publication of the main results.', 'ipdSharing': 'YES', 'description': 'After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.', 'accessCriteria': 'All of the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yao Yusheng', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}