Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-02 @ 6:07 PM
Study NCT ID:
NCT02613806
Status:
UNKNOWN
Last Update Posted:
2015-11-25
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-23', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-23', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of coughing', 'timeFrame': 'within 48 hours postoperatively', 'description': 'coughing will be observed'}], 'secondaryOutcomes': [{'measure': 'coughing on a four-point scale', 'timeFrame': 'within 48 hours postoperatively', 'description': 'coughing on a four-point scale will be measured within 48 hours postoperatively'}, {'measure': 'the eyes opening time', 'timeFrame': 'within 48 hours postoperatively', 'description': 'the eyes opening time will be observed'}, {'measure': 'the time of extubation', 'timeFrame': 'within 48 hours postoperatively', 'description': 'the time of extubation will be recorded'}, {'measure': 'visual analogue scale (VAS)', 'timeFrame': 'at 30 minutes after extubation', 'description': 'visual analogue scale will be measured at 30 minutes after extubation'}, {'measure': 'sedation-agitation scale(SAS)', 'timeFrame': 'at 30 minutes after extubation', 'description': 'sedation-agitation scale will be measured at 30 minutes after extubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Coughing Response', 'Postoperative Recovery Quality', 'Thyroid Surgery'], 'conditions': ['Coughing Response', 'Thyroid Surgery', 'General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '17379129', 'type': 'BACKGROUND', 'citation': 'Bergese SD, Khabiri B, Roberts WD, Howie MB, McSweeney TD, Gerhardt MA. Dexmedetomidine for conscious sedation in difficult awake fiberoptic intubation cases. J Clin Anesth. 2007 Mar;19(2):141-4. doi: 10.1016/j.jclinane.2006.07.005.'}, {'pmid': '20039221', 'type': 'BACKGROUND', 'citation': 'Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.'}, {'pmid': '16402208', 'type': 'BACKGROUND', 'citation': 'Kiray A, Naderi S, Ergur I, Korman E. Surgical anatomy of the internal branch of the superior laryngeal nerve. Eur Spine J. 2006 Sep;15(9):1320-5. doi: 10.1007/s00586-005-0006-7. Epub 2006 Jan 5.'}, {'pmid': '11046225', 'type': 'BACKGROUND', 'citation': 'Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.'}, {'pmid': '22824921', 'type': 'BACKGROUND', 'citation': 'Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.'}, {'pmid': '25132201', 'type': 'BACKGROUND', 'citation': 'Ham SY, Kim JE, Park C, Shin MJ, Shim YH. Dexmedetomidine does not reduce emergence agitation in adults following orthognathic surgery. Acta Anaesthesiol Scand. 2014 Sep;58(8):955-60. doi: 10.1111/aas.12379.'}]}, 'descriptionModule': {'briefSummary': 'Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative bleeding.Postoperative bleeding is a serious and potentially life-threatening complication，which could result in acute upper airway obstruction due to neck hematoma and increase the need for re-operation.The purpose of this study is to investigate whether dexmedetomidine can reduce the incidence of postoperative coughing and contribute to postoperative recovery in patients undergoing tyroid surgery with general anesthesia.', 'detailedDescription': "Thyroid surgery is a common clinical surgery,the incidence of postoperative coughing is up to 32.4%.Coughing response could result in postoperative bleeding,even cause respiratory tract obstruction,affect patients' postoperative recovery .Dexmedetomidine,an α2 adrenergic agonist,has hypnotic,analgesic, anxiolytic,antisympathetic effects,which could facilitate the sedation of patients while maintaining their consciousness and keep respiration and circulation stable .For these benefits,dexmedetomidine was widely used for general anesthesia.However,whether dexmedetomidine can reduce the incidence of postoperative coughing is unclear.Therefore,the investigators conduct this randomized controlled double-blind trial,to investigate the effects of dexmedetomidine on coughing and postoperative recovery quality in patients undergoing tyroid surgery with general anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged from 18 to 65 years old\n2. American Society of Anesthesiologists (ASA) physical statusⅠor Ⅱ\n3. Diagnosed by B ultrasonic or tissue biopsy show that patients thyrophyma,thyroid cancer,thyroid nodule,etc,who need to accept thyroid surgery\n\nExclusion Criteria:\n\n1. large goiter or hyperthyroidism\n2. Preoperative coughing caused by primary diseases of patients\n3. Ⅱdegrees above atrioventricular block\n4. Allergy to anesthesia\n5. History of diabetes\n6. Pregnant women\n7. Serious mental disease\n8. History of alcohol or drug abuse\n9. Severe heart renal or liver dysfunction\n10. The presence of an upper respiratory infection\n11. Asthma\n12. Anticipated difficult airway'}, 'identificationModule': {'nctId': 'NCT02613806', 'briefTitle': 'Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General anesthesia---a Randomized Control Double-Blind Clinical Trial', 'orgStudyIdInfo': {'id': 'CYYYMZK-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D group (dexmedetomidine)', 'description': 'Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion with microperfusion pump at the beginning of the surgery,and continued till end of surgery.', 'interventionNames': ['Drug: Dexmeditomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C group (saline)', 'description': 'The patients received equal volume normal saline by intravenous infusion at the beginning of the surgery,and continued till end of surgery.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Dexmeditomidine', 'type': 'DRUG', 'description': 'Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.', 'armGroupLabels': ['D group (dexmedetomidine)']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Isovolumetric normal saline will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.', 'armGroupLabels': ['C group (saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Su Min, MD.', 'role': 'CONTACT', 'email': 'ms89011068@163.com', 'phone': '+86-23-89011068'}], 'facility': 'The First Affliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yanping Zhang, Master', 'role': 'CONTACT', 'email': '398254227@qq.com', 'phone': '023-89011061'}], 'overallOfficials': [{'name': 'Su Min', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The Department of Anesthesia and Pain Medicine', 'investigatorFullName': 'Min Su', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}