Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-25 @ 3:07 AM
Study NCT ID:
NCT02141412
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2014-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2014-05-15', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postanaesthetic shivering incidence and score', 'timeFrame': 'change from baseline every 10 minutes up to 1 hour post-operatively'}, {'measure': 'Quality of emergence from anesthesia', 'timeFrame': 'Change from baseline every 5 minutes till extubation', 'description': 'The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation'}], 'secondaryOutcomes': [{'measure': "Patient's Temperature", 'timeFrame': 'every 10 minutes up to 1 hour post-operatively'}, {'measure': 'Time to extubation, awakening and orientation', 'timeFrame': '1 hour post-operatively'}, {'measure': 'Sedation scores', 'timeFrame': 'every 10 minutes up to 1 hour post-operatively'}, {'measure': 'Pain scores', 'timeFrame': 'every 10 minutes up to 1 hour post-operatively'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'every 10 minutes up to 1 hour post-operatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['optimal dose of dexmedetomidine', 'prevent shivering', 'improve quality of emergence', 'anesthesia', 'without delay', 'recovery'], 'conditions': ['Anesthesia Recovery', 'Anesthesia Emergence', 'Shivering', 'Postoperative Recovery']}, 'descriptionModule': {'briefSummary': 'In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.', 'detailedDescription': 'Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 year-old\n* ASA class I, II, and III\n* patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h\n\nExclusion Criteria:\n\n* duration of surgery less than 1h or more than 3 h\n* allergy to dexmedetomidine\n* vasoactive antidepressant or analgesics\n* obesity (BMI\\>30)\n* fever\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02141412', 'briefTitle': 'Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study', 'orgStudyIdInfo': {'id': 'ANES.MA.10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane', 'interventionNames': ['Drug: dexmedetomidine 0.25 µg/kg IV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane', 'interventionNames': ['Drug: dexmedetomidine 0.5 µg/kg IV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': 'Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane', 'interventionNames': ['Drug: dexmedetomidine 1 µg/kg IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group IV', 'description': 'Patients in Group IV will receive same volume of normal saline at closure of sevoflurane', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'dexmedetomidine 0.25 µg/kg IV', 'type': 'DRUG', 'armGroupLabels': ['Group I']}, {'name': 'dexmedetomidine 0.5 µg/kg IV', 'type': 'DRUG', 'armGroupLabels': ['Group II']}, {'name': 'dexmedetomidine 1 µg/kg IV', 'type': 'DRUG', 'armGroupLabels': ['Group III']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Patients in Group IV will receive same volume of normal saline at closure of sevoflurane', 'armGroupLabels': ['Group IV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Marie Aouad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Univesity of Beirut Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Specialty', 'investigatorFullName': 'Dr. Marie Awad', 'investigatorAffiliation': 'American University of Beirut Medical Center'}}}}