Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-22 @ 7:46 PM
Study NCT ID:
NCT06507202
Status:
RECRUITING
Last Update Posted:
2024-07-18
First Post:
2024-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fit-for-discharge time', 'timeFrame': '15 minutes after surgery', 'description': 'Evaluated on a scale of 0 to 10 through the Modified Post Anesthetic Discharge Scoring System (MPADSS); a score of 9 or higher meets the discharge criteria.'}], 'secondaryOutcomes': [{'measure': 'Time to eye opening, time to extubate, time to postanesthetic care unit (PACU) transfer', 'timeFrame': '1 minute', 'description': 'Measured at operating room, using a timer from the end of surgery'}, {'measure': 'postanesthetic care unit (PCAU) stay time, Day surgery center stay time', 'timeFrame': '5 minutes', 'description': 'Measured from entering to exiting each units'}, {'measure': 'Incidence of adverse events', 'timeFrame': '6 hours', 'description': 'Including desaturation, laryngospasm, hypotension, bradycardia, hemodynamic agent administration, emergence agitation, headache, dizziness, somnolence, cough, shivering, postoperative nausea \\& vomiting'}, {'measure': 'Postoperative pain score', 'timeFrame': '6 hours', 'description': '11-point NRS (0-10); for the worst pain'}, {'measure': "modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival", 'timeFrame': '30 minutes', 'description': 'Evaluated on a scale of 0 to 5'}, {'measure': 'modified Aldrete score at PACU arrival', 'timeFrame': '30 minutes', 'description': 'Evaluated on a scale of 0 to 10'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remimazolam', 'upper airway surgery', 'ambulatory surgery'], 'conditions': ['Laryngeal Disease', 'Pharyngeal Diseases', 'Oral Cavity Disease', 'Nasal Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of remimazolam and propofol on postoperative recovery time, complications, and safety in patients undergoing ambulatory upper airway surgery under general anesthesia.', 'detailedDescription': 'Patients scheduled for ambulatory upper airway (including nasal cavity, oral cavity, pharynx, larynx) surgery and who agree to participate in the study will be randomly assigned to the Remimazolam group and the Propofol group. In the Remimazolam group, general anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil. Once the surgery is completed, general anesthesia is recovered with flumazenil. In the Propofol group, general anesthesia is induced and maintained by continuous infusion of propofol and remifentanil using a target concentration controlled infusion method. In both groups, rocuronium is used for neuromuscular blokade, and sugammadex is used for reversal of neuromuscular blockade.\n\nWhen the surgery is completed, recovery time, occurrence of adverse events, and anesthesia recovery indicators are examined in 3 stages: in the operating room, while staying in the post-anesthesia care unit(PACU), and while staying in the day surgery center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age 19 or older) undergoing ambulatory upper respiratory tract (nasal cavity, oral cavity, pharynx, larynx) surgery under general anesthesia\n* American Society of Anesthesiologists physical class classification I, II, and III\n\nExclusion Criteria:\n\n* Patients who refused to participate in the study\n* Pregnant patients\n* Patients with a history of hypersensitivity to drugs or additives used during surgery\n* Patients with acute narrow-angle glaucoma\n* Alcohol or drug dependent patients\n* Patients with Child-Pugh class C liver dysfunction'}, 'identificationModule': {'nctId': 'NCT06507202', 'briefTitle': 'Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University Gwangmyeong Hospital'}, 'officialTitle': 'Comparison of Remimazolam Versus Propofol-based General Anesthesia on Postoperative Quality of Recovery in Patients Undergoing Ambulatory Upper Airway Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2311123132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam group', 'description': 'General anesthesia is induced by continuously injecting remimazolam (6 mg/kg/h) and remifentanil (2-6 ng/ml, target concentration controlled infusion) through an infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6 mg/kg is injected for endotracheal intubation, and anesthesia is maintained with remimazolam (1-2 mg/kg/hr) and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated with flumazenil and sugammadex.', 'interventionNames': ['Drug: Remimazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'General anesthesia is induced by continuously injecting propofol (2-6 mg/ml, target concentration controlled injection) and remifentanil (2-6 ng/ml, target concentration controlled injection) using a TCI infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6mg/kg is injected for endotracheal intubation, and anesthesia is maintained with propofol and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated through sugammadex.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'otherNames': ['Byfavo'], 'description': 'General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil.', 'armGroupLabels': ['Remimazolam group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Fresofol'], 'description': 'General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14353', 'city': 'Gyeonggi-do', 'state': 'Gwangmyeon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seihee Min', 'role': 'CONTACT', 'email': 'seiheemin@gmail.com', 'phone': '821054004892'}], 'facility': 'ChungAng University Gwangmyeong Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'centralContacts': [{'name': 'Se-Hee Min', 'role': 'CONTACT', 'email': 'seiheemin@gmail.com', 'phone': '+820222221534'}], 'overallOfficials': [{'name': 'Se-Hee Min', 'role': 'STUDY_CHAIR', 'affiliation': 'Chung-Ang University Gwangmyeong Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University Gwangmyeong Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Se-Hee Min', 'investigatorAffiliation': 'Chung-Ang University Gwangmyeong Hospital'}}}}