Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT05751603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-25
First Post:
2023-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extubation quality score', 'timeFrame': 'immediate after extubation', 'description': 'score based on the incidence and severity of coughing straining'}], 'secondaryOutcomes': [{'measure': 'time to respiration', 'timeFrame': 'immediate after extubation', 'description': 'time from withdrawal of anesthetics to respiration'}, {'measure': 'time to extubation', 'timeFrame': 'immediate after extubation', 'description': 'time from withdrawal of anesthetics to extubation'}, {'measure': 'sore throat in postanesthetic care unit', 'timeFrame': 'in postanesthetic care unit', 'description': 'Scores obtained by questioning the patient in postanesthetic care unit'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sugammadex', 'Extubation', 'Smooth Emergence']}, 'descriptionModule': {'briefSummary': 'After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. These phenomena can lead to high intrathoracic pressure, venous congestion, hematoma formation, or increased bleeding after major neck surgery. (1) They can also increase the risk of aerosol generation, which can transmit infection to health care workers. (2) For this, smooth extubation is required. Methods of administering drugs such as lidocaine, opioids, or dexmedetomidine have been proposed for smooth extubation. (3-5) As a disadvantage, the use of these drugs may be associated with deep sedation and reduced airway reflexes .\n\nRecently, Babu et al. (6) reported that bucking and coughing during extubation could be reduced by changing the timing of administering a muscle relaxant antagonist rather than using these sedative drugs, and thus complications related to extubation could be reduced. In general, in the awakening process, it was common to administer the muscle relaxant at the point of recovery of spontaneous breathing. However, Babu et al. demonstrated the possibility of safe and smooth extubation by changing the timing of administering neostigmine without the use of sedatives or narcotic analgesics, but there are few studies on sugammadex.\n\nTherefore, when recovering from general anesthesia, sugammadex was administered before and immediately after extubation to evaluate and compare smooth extubation (ie, comparison of the frequency of bucking and coughing).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing general anesthesia for thyroid surgery.\n* aged between 19 and 64 years\n* American Society of Anesthesiologists physical status I and II\n\nExclusion Criteria:\n\n* patients with malformation or tumor of the upper respiratory tract\n* patients with risk of aspiration\n* obese cases with a BMI \\> 35\n* patients in which tracheal intubation was difficult\n* refusal to participate in research'}, 'identificationModule': {'nctId': 'NCT05751603', 'briefTitle': 'Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of Smooth Emergence During Extubation After Anesthesia When Sugammadex is Administered Before and After Extubation', 'orgStudyIdInfo': {'id': 'AJOUIRB-INT-2022-173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Routine anesthetic process; sugammadex is administered when spontaneous respiration is returned (before extubation)'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'sugammadex is administered just after extubation.', 'interventionNames': ['Drug: sugammadex']}], 'interventions': [{'name': 'sugammadex', 'type': 'DRUG', 'description': 'sugammadex is administered just after extubation', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yun jeong chae, Ph D', 'role': 'CONTACT', 'email': 'yjchae06@hotmail.com', 'phone': '+82312195689'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'yun jeong chae', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}