Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-04-16 @ 9:41 AM
Study NCT ID:
NCT01617694
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-11', 'studyFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coughing response', 'timeFrame': 'from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.', 'description': 'Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'remifentanil', 'target-controlled infusion'], 'conditions': ['Thyroid Neoplasm']}, 'referencesModule': {'references': [{'pmid': '19411668', 'type': 'BACKGROUND', 'citation': 'Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.'}, {'pmid': '16095449', 'type': 'BACKGROUND', 'citation': 'Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.'}, {'pmid': '18400140', 'type': 'BACKGROUND', 'citation': 'Turan G, Ozgultekin A, Turan C, Dincer E, Yuksel G. Advantageous effects of dexmedetomidine on haemodynamic and recovery responses during extubation for intracranial surgery. Eur J Anaesthesiol. 2008 Oct;25(10):816-20. doi: 10.1017/S0265021508004201. Epub 2008 Apr 10.'}, {'pmid': '19864308', 'type': 'BACKGROUND', 'citation': 'Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patient,\n* aged 20-60 yr,\n* ASA physical status 1-2,\n* patients undergoing elective thyroidectomy under general anesthesia\n\nExclusion Criteria:\n\n* sighs of difficult airway,\n* history of respiratory disease or chronic cough,\n* cardiovascular disease,\n* pregnant or breast-feeding woman.'}, 'identificationModule': {'nctId': 'NCT01617694', 'briefTitle': 'Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2011-0181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group R', 'description': 'continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation.', 'interventionNames': ['Drug: dexmedetomidine', 'Drug: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group D', 'description': 'remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery', 'interventionNames': ['Drug: dexmedetomidine', 'Drug: Normal Saline']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'description': "Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.", 'armGroupLabels': ['group D', 'group R']}, {'name': 'Normal Saline', 'type': 'DRUG', 'armGroupLabels': ['group D', 'group R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}