Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-05 @ 6:25 PM
Study NCT ID:
NCT04628559
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The surgeon and observers were all blinded to the patients until the end of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. First arm received dexmedetomidine\n2. Second arm received ketamine\n3. Third arm received saline solution.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2009-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-13', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to verbal stimulus time', 'timeFrame': '0-120 minutes following finishing operation', 'description': 'Verbal response received when the patient was spoken to'}, {'measure': 'Intraoperative additional fentanyl requirement', 'timeFrame': '0-120 minutes following initiating operation', 'description': 'Intraoperative additional fentanyl requirement for pain relief and'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '0-120 minutes', 'description': 'Heart rate during operation and following operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Ketamine', 'Perioperative effects'], 'conditions': ['Anesthesia', 'Intravenous Anesthetic Toxicity']}, 'descriptionModule': {'briefSummary': 'This randomized double-blind study aimed to compare the effects of dexmedetomidine and ketamine on hemodynamic parameters, recovery criteria, and opioid consumption and advers effects in septorhinoplasty operations. Totally 63 patients were included.\n\nThe groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.', 'detailedDescription': 'A total of 63 patients 18-55 years undergoing septorhinoplasty, who were graded as American Society of Anesthesiologists physical status were randomly allocated into three groups, receiving dexmedetomidine (n=21, Group D), ketamine (n=21, Group K) and saline solution (n=21, Group S). Anesthesia was induced with propofol, cisatracurium and fentanyl. Maintenance anesthesia was done with 2-2.5% sevoflurane mixture, 50-60% oxygen and N2O. The groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient graded as American Society of Anesthesiologist (ASA) physical status, I or II\n* Patient subjected to septorhineoplasty operation\n\nExclusion Criteria:\n\n* Patient having morbid obesity,\n* Patient having yypertension,\n* Patient having Asthma,\n* Patient having neuropsychiatric disease,\n* Patient allergy to the study drugs.'}, 'identificationModule': {'nctId': 'NCT04628559', 'briefTitle': 'Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations', 'orgStudyIdInfo': {'id': '2009/137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomine', 'description': 'Patients recieving Dexmedetomidine.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine', 'description': 'Patients recieving Ketamine.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients recieving Saline.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Group D'], 'description': 'dexmedetomidine was administered as a gradual bolus of 1 µg/kg/10ml 10 min before induction of anesthesia and then as an infusion of 0.4 µg/kg per min (30 ml/h). In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).', 'armGroupLabels': ['Dexmedetomine']}, {'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Group K'], 'description': 'In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).', 'armGroupLabels': ['Ketamine']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Group S'], 'description': 'Group S was given a bolus of saline solution in 10 ml volume 10 min before induction of anesthesia, followed by 30 mL/h serum saline infusion.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Medical School of Karadeniz Technical University, Department of Anesthesiology', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Muge Muge, Assoc Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical School of Karadeniz Technical University, Department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associated Professor', 'investigatorFullName': 'Muge Kosucu', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}