Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-08 @ 12:50 PM
Study NCT ID:
NCT03398759
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2018-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002077', 'term': 'Butorphanol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-08', 'studyFirstSubmitDate': '2018-01-03', 'studyFirstSubmitQcDate': '2018-01-06', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emergence agitation incidence', 'timeFrame': '1 hour in the post anesthesia care unite(PACU)', 'description': 'Emergence agitation incidence'}], 'secondaryOutcomes': [{'measure': 'MAP', 'timeFrame': '1 hour in the post anesthesia care unite(PACU)', 'description': 'The mean arterial pressure'}, {'measure': 'HR', 'timeFrame': '1 hour in the post anesthesia care unite(PACU)', 'description': 'Heart rate'}, {'measure': 'quality of recovery -40 questionnaire', 'timeFrame': '24h after operation', 'description': 'Measurement of quality of recovery with QoR-40'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Butorphanol', 'Functional endoscopic sinus surgery', 'Emergence agitation'], 'conditions': ['Agitation']}, 'referencesModule': {'references': [{'pmid': '36733413', 'type': 'DERIVED', 'citation': 'Zhang X, Qi S, Lin Z, Zhang Y, Dai W, Tian W, Tian J, Zheng L, Su D, Huai X. Pre-operative administration of butorphanol mitigates emergence agitation in patients undergoing functional endoscopic sinus surgery: A randomized controlled clinical trial. Front Psychiatry. 2023 Jan 17;13:1090149. doi: 10.3389/fpsyt.2022.1090149. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Emergence agitation is one of the common postoperative complications after functional endoscopic sinus surgery（FESS). The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.', 'detailedDescription': 'Butorphanol is a mixed agonist-antagonist opioid with strong κappa-receptor agonist and weak mu-receptor antagonist activity. It is commonly used for the management of cancer, postoperative, gynecologic, and obstetric pain. Additionally, Butorphanol has less respiratory depression and sedation effects, which make it may become a good medicine to alleviate the agitation. However, there is no clinical evidence to confirmation of such effectiveness of butorphanol. The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>=18 years,\\<=65years;\n2. height 150-180 cm;\n3. weight 55-80 kg;\n4. Signed the inform consent\n5. American Society of Anesthesiologists classification I to II\n6. Select to functional endoscopic sinus surgery\n\nExclusion Criteria:\n\n1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;\n2. Several audition or vision disorder;\n3. Unwillingness to comply with the protocol or procedures.\n4. Can not communicated with Chinese Mandarin\n5. Existing bradycardiac arrhythmia（Heart rate \\<60 bpm for any reasons）\n6. Existing gastrointestinal ulcer\n7. Existing urinary incontinence\n8. Existing asthma or chronic obstructive pulmonary disease\n9. Allegory to Butorphanol'}, 'identificationModule': {'nctId': 'NCT03398759', 'briefTitle': 'Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery：a Randomized Control Double Blinded Clinical Trail', 'orgStudyIdInfo': {'id': 'FNPA2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Butorphanol', 'description': 'Butorphanol 20ug/kg , anesthesia induction，Intravenous injection', 'interventionNames': ['Drug: Butorphanol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline 5ml ， anesthesia induction，Intravenous injection', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Butorphanol', 'type': 'DRUG', 'description': 'IV injection during induction', 'armGroupLabels': ['Butorphanol']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'IV injection during induction', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaorong Huai, MS', 'role': 'CONTACT', 'email': 'smile_huai@126.com', 'phone': '+8613818003683'}, {'name': 'Diansan Su, M.D., Ph.D', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088'}, {'name': 'Xiaorong Huai, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renji Hospital, Shanghai Jiao Tong University, School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaorong Huai, MS', 'role': 'CONTACT', 'email': 'smile_huai@126.com', 'phone': '+8613818003683'}, {'name': 'Diansan Su, MD', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088'}], 'overallOfficials': [{'name': 'Weifeng Yu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Anesthesiology Department Renji Hospital, Shanghai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident physician', 'investigatorFullName': 'Xiaorong Huai', 'investigatorAffiliation': 'RenJi Hospital'}}}}