Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-04 @ 11:11 PM
Study NCT ID:
NCT03559920
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2018-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011184', 'term': 'Postoperative Period'}], 'ancestors': [{'id': 'D059035', 'term': 'Perioperative Period'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal end-tidal sevoflurane concentration to induce moderate sedation of RASS -2~-3 in patients who undergo head & neck surgery with tracheostomy', 'timeFrame': 'After the first 30 minutes after sedation with sevoflurane via anesthetic conserving device', 'description': "Investigators will find the initial concentration of sevoflurane for proper sedation by the Dixon's up and down method."}], 'secondaryOutcomes': [{'measure': 'Compare the sevoflurane group and the intravenous sedation group: Compare the ICU stay', 'timeFrame': 'within the 3 days (plus of minus 3 days) after surgery'}, {'measure': 'Compare the sevoflurane group and the intravenous sedation group: Compare the hospital day', 'timeFrame': 'within the 3 days (plus of minus 3 days) after surgery'}, {'measure': 'Compare the sevoflurane group and the intravenous sedation group: Compare the incidence of delirium, hypotension', 'timeFrame': 'within the 3 days (plus of minus 3 days) after surgery'}, {'measure': 'Compare the sevoflurane group and the intravenous sedation group: Compare the remifentanil infusion dose', 'timeFrame': 'within the 3 days (plus of minus 3 days) after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Who Needs Sedation After Head & Neck Surgery']}, 'descriptionModule': {'briefSummary': 'Sedation in the ICUs is very common. There is no ideal sedative yet, so research has been conducted to replace propofol and midazolam, which are the most commonly used sedatives in ICUs, by inhalation anesthetics. The investigators will sedate the patients who undergo head \\& neck surgery with tracheostomy for several days using sevoflurane, a kind of inhalation agent, via anesthetic conserving device.\n\nThe objective of this study is to confirm the end-tidal sevoflurane concentration for inducing moderate sedation (RASS -2\\~-3). In addition, the investigators compare the volatile sedation with the IV(intravenous) sedation to see if the volatile sedation could reduce the amount of post-operative opioid consumption.\n\n* RASS: Richmond Agitation-Sedation Scale\n* RASS: Richmond Agitation-Sedation Scale', 'detailedDescription': "When patients, who need mechanical ventilation for several days after head \\& neck surgery, enters the ICU, the investigators induce moderate sedation (RASS -2\\~-3). End-tidal sevoflurane (etSEVO) concentration is adjusted to 0.5Vol% within 30 minutes. Sedation level is evaluated every 5 minutes. After 30 minutes, the investigators check that the sedation goal is achieved.\n\nFollowing the up \\& down method, if the moderate sedation (RASS -2\\~-3) or the deep sedation (RASS -4\\~-5) is achieved at the etSEVO concentration of 0.5vol% after 30 minutes of sedation, the next patient's target etSEVO concentration is reduced to 0.4vol%. On the contrary to this, if only light sedation (RASS above -1) is achieved, the next patient's target etSEVO is increased to 0.6vol%. This process is repeated to find the appropriate etSEVO concentration at the beginning of sedation, which induces sedation of RASS -2\\~-3.\n\nIn retrospective analysis, the investigators compared the prospective study group with propofol intravenous sedation group.\n\n\\* RASS: Richmond Agitation-Sedation Scale"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who needs sedation in the ICU for several days after head \\& neck surgery\n* ASA class I\\~III\n* Adult patients over 20 years old\n* Patients who can read and understand the informed consent\n\nExclusion Criteria:\n\n* Patients who do not agree to participate in the study\n* Past history or Family history of malignant hyperthermia\n* End stage renal disease (eGFR\\<30 or dialysis)\n* Moderate to severe liver disease (AST, ALT \\> 200IU/L)\n* Pregnant women\n* Patients who cannot read and understand the informed consent'}, 'identificationModule': {'nctId': 'NCT03559920', 'briefTitle': 'The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery', 'orgStudyIdInfo': {'id': '4-2018-0065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane group', 'description': 'Patients who are sedated using sevoflurane', 'interventionNames': ['Drug: Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous sedation group', 'description': 'Patients who are sedated using propofol', 'interventionNames': ['Drug: Sedate using propofol.']}], 'interventions': [{'name': 'Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery', 'type': 'DRUG', 'description': 'The investigators sedate the patients in the ICU for several days after head \\& neck surgery using sevoflurane via anesthetic conserving device in sevoflurane group.', 'armGroupLabels': ['Sevoflurane group']}, {'name': 'Sedate using propofol.', 'type': 'DRUG', 'description': 'Retrospectively, the investigators compare the sevoflurane group with intravenous sedation group using propofol.', 'armGroupLabels': ['Intravenous sedation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}