Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT01851005
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2013-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine on Recovery Profiles of Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-18', 'studyFirstSubmitDate': '2013-04-30', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Side effects', 'timeFrame': 'Participants will be followed for the duration of postanesthetic care unit stay, an expected average of 1 hour', 'description': 'The incidence of nausea, vomiting, hypotension, hypertension, bradycardia, and tachycardia (During surgery and staying in postanesthetic care unit)'}, {'measure': 'Recovery time (2)', 'timeFrame': 'At the end of surgery and anesthesia, an expected average of 15 minutes', 'description': 'Time to recover BIS 60, 70, and 80.'}], 'primaryOutcomes': [{'measure': 'Recovery time (1)', 'timeFrame': 'At the end of surgery and anesthesia, an expected average of 15 minutes', 'description': 'Time to eye opening.'}], 'secondaryOutcomes': [{'measure': 'Ricker scale', 'timeFrame': 'About 5 minutes after end of surgery and anesthesia', 'description': 'Time to eye opening Ricker sedation-agitated scale in PACU (At the times of arrival and leaving postanesthetic care unit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Anesthesia', 'Recovery profile'], 'conditions': ['Elderly Patients', 'Anesthesia', 'Emergence From Anesthesia', 'Effects of Dexmedetomidine', 'Recovery From Anesthesia']}, 'referencesModule': {'references': [{'pmid': '9296424', 'type': 'BACKGROUND', 'citation': 'Juvin P, Servin F, Giraud O, Desmonts JM. Emergence of elderly patients from prolonged desflurane, isoflurane, or propofol anesthesia. Anesth Analg. 1997 Sep;85(3):647-51. doi: 10.1097/00000539-199709000-00029.'}, {'pmid': '20705788', 'type': 'BACKGROUND', 'citation': 'Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.'}, {'pmid': '20177939', 'type': 'BACKGROUND', 'citation': 'Tei M, Ikeda M, Haraguchi N, Takemasa I, Mizushima T, Ishii H, Yamamoto H, Sekimoto M, Doki Y, Mori M. Risk factors for postoperative delirium in elderly patients with colorectal cancer. Surg Endosc. 2010 Sep;24(9):2135-9. doi: 10.1007/s00464-010-0911-7. Epub 2010 Feb 23.'}, {'pmid': '16670111', 'type': 'BACKGROUND', 'citation': 'Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.'}, {'pmid': '26446479', 'type': 'DERIVED', 'citation': 'Kim DJ, Kim SH, So KY, Jung KT. Effects of dexmedetomidine on smooth emergence from anaesthesia in elderly patients undergoing orthopaedic surgery. BMC Anesthesiol. 2015 Oct 7;15:139. doi: 10.1186/s12871-015-0127-4.'}]}, 'descriptionModule': {'briefSummary': 'Emergence of elderly patients from anesthesia may face with cognitive dysfunction or agitation such as delirium. There are reports that using dexmedetomidine as a adjuvant for general anesthesia decreased emergence-agitation in children and dexmedetomidine may be used for treating deliriums. Thus, we thought that dexmedetomidine as a adjuvant agent may be a help to smooth emergence from anesthesia in elderly.\n\nThe aims of this study were to investigate the recovery characteristics (time to recovery of consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients undergoing elective surgery.', 'detailedDescription': 'Purpose: The aims of this study were to investigate the recovery characteristics (time to recovery of consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients undergoing elective surgery.\n\nHypothesis: Dexmedetomidine as a adjuvant agent may be a help to smooth emergence from anesthesia in elderly.\n\nObjectives: Patients who are scheduled to undergo elective surgery, American society of anesthesiologist class (ASA) I-II, aged over 65 years, are randomly allocated into six groups.\n\n* Group 1: general anesthesia with sevoflurane only (placebo: normal saline)\n* Group 2: general anesthesia with propofol and remifentanil (total intravenous anesthesia) only (placebo: normal saline)\n* Group 3: general anesthesia with sevoflurane and adjuvant dexmedetomidine\n* Group 4: general anesthesia with propofol and remifentanil (total intravenous anesthesia), and adjuvant dexmedetomidine\n\nResearch Method: Once in the operating room, patients were monitored with electrocardiography, non invasive blood pressure, pulse oximetry (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and BIS (Aspect 2000, Aspect Medical Systems, Inc., Newton, MA, USA).\n\nIn the group 1 and group 3, anesthesia was induced with propofol (2mg/kg) and followed by administering rocuronium 0.6 mg/kg. After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2), and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 45 mmHg. The concentrations of sevoflurane was adjusted for maintain BIS score between 40 and 45.\n\nIn the group 2 and group 4, anesthesia was induced and maintained with total intravenous anesthesia using propofol and remifentanil. Effective site concentration of propofol and remifentanil were adjusted for maintain BIS between 40 and 45 and maintain changes of vital sign between 20% of baseline value.\n\nIn the group 3 and group 4, dexmedetomidine was administered (0.4 ug/kg/hr) during surgery. Instead, in the group 1 and group 2, normal saline was administered with same rate as a placebo.\n\nThe concentrations of sevoflurane was measured continuously using an infrared anesthetic gas analyzer (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and the effect site concentration of propofol and remifentanil also measured with target controlled infuser (Orchestra® Base Primea, Fresenius-Vial, France) during surgery.\n\nAfter the end of surgery, all anesthetics or dexmedetomidine was discontinued and the time to recovery BIS score until 60, 70, and 80 were measured. Patients were asked to open their eyes and the time of eye opening were measured. After the eye opening, reversal agent was administered and the patients were transferred to postanesthetic care unit (PACU).\n\nAfter arrival on PACU, blood pressure, heart rate, and Ricker sedation-agitated scale were measure every 5 minutes. When the Ricker sedation-agitated scale became 4, patients were transferred to ward, and the time of staying in postanesthetic care unit were measured.\n\nThe incidence of nausea, vomiting, hypotension, hypertension, bradycardia, and tachycardia was measured during surgery and staying in postanesthetic care unit.\n\nAll participants will be followed for the duration of surgery and postanesthetic care unit stay, an expected average of 1 day.\n\nStatistical Analysis: All data are expressed as mean ± standard deviation. Recovery profiles (time to recovery of consciousness (ROC) and recovery, BIS values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) were analyzed by paired t-test. And the incidence of nausea/vomiting, hypotension, hypertension, bradycardia, and tachycardia was analyzed by Chi-square test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Age \\> 65\n* Elective surgery\n\nExclusion Criteria:\n\n* Patients with severe heart disease with New York Heart Association class \\> III\n* Patients with severe arrhythmia\n* Patients with uncontrolled hypertension or hypotension\n* Patients with hemodynamic unstably\n* Patients with hypersensitivity with drugs\n* Patients with cognitive deficiency, dementia, or delirium\n* Patients with hepatic or renal compromise\n* Patients with infective disease'}, 'identificationModule': {'nctId': 'NCT01851005', 'acronym': 'CSUHAPM', 'briefTitle': 'Effect of Dexmedetomidine on Recovery Profiles of Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chosun University Hospital'}, 'officialTitle': 'Effect of Dexmedetomidine on Recovery Profiles of Elderly Patients', 'orgStudyIdInfo': {'id': 'DEX-RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1', 'description': 'General anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.', 'interventionNames': ['Drug: Sevoflurane', 'Drug: Normal saline', 'Drug: Rocuronium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.', 'interventionNames': ['Drug: Propofol and Remifentanil', 'Drug: Normal saline', 'Drug: Rocuronium']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'General anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Sevoflurane', 'Drug: Rocuronium']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of dexmedetomidine (0.4 ug/kg/hr) during surgery. Administer rocuronium 0.8 mg/kg for induction.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Propofol and Remifentanil', 'Drug: Rocuronium']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Infusion of dexmedetomidine (0.4 ug/kg/hr)', 'armGroupLabels': ['Group 3', 'Group 4']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevorane'], 'description': 'Control Vol% to maintain BIS 40\\~45', 'armGroupLabels': ['Group 1', 'Group 3']}, {'name': 'Propofol and Remifentanil', 'type': 'DRUG', 'otherNames': ['Total intravenous anesthesia'], 'description': 'Control effect site concentration for maintain BIS 40\\~45 and changes of vital signs within 20%.', 'armGroupLabels': ['Group 2', 'Group 4']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Use as placebo', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['Muscle relaxation during general anesthesia'], 'description': '0.8 mg/kg for induction', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '501-717', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Ki Tae Jung, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology and Pain medicine School of Medicine, Chosun University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chosun University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist Professor, Principal Investigator, Clinical Professor of Department of Anesthesiology and Pain medicine, School of Medicine, Chosun University', 'investigatorFullName': 'Ki Tae Jung', 'investigatorAffiliation': 'Chosun University Hospital'}}}}