Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-21 @ 1:52 AM
Study NCT ID:
NCT04018157
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2019-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'patient and outcomes assessor'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2019-07-04', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of emergence agitation.', 'timeFrame': 'up to 60 minutes after extubation', 'description': 'The incidence of emergence agitation.'}, {'measure': 'The level of emergence agitation.', 'timeFrame': 'up to 60 minutes after extubation', 'description': 'The level of emergence agitation measured by . Richmond Agitation-Sedation scale (RASS) is ten scales; five for sedation level ,one for alertness and calmness, and four for agitation level as follow: -5 unarousable , -4 deep sedation , -3 moderate sedation , -2 light sedation , -1 drowsy ; 0 alert and calm,+1 restless , +2 agitated , +3 very agitated and +4 combative. Patients with score ≥ 2 considered having agitation.'}], 'secondaryOutcomes': [{'measure': 'The Emergence time', 'timeFrame': 'up to 20 minutes after discontinuation of isoflurane', 'description': 'The time from discontinuation of isoflurane to first response to verbal command.'}, {'measure': 'The extubation time', 'timeFrame': 'up to 20 minutes after discontinuation of isoflurane', 'description': 'time from discontinuation of isoflurane to extubation.'}, {'measure': 'The time of discharge', 'timeFrame': 'up to 40 minutes after extubation', 'description': 'The time from arrival to postanesthesia care unite (PACU) to discharge to the ward according to modified aldert score'}, {'measure': 'Postoperative Pain is evaluated using Numerical rating Scale (NRS)', 'timeFrame': 'up to 40 minutes after extubation', 'description': '(NRS) A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.'}, {'measure': '"Number of Participants with vomiting or hypotension or bradycardia"', 'timeFrame': 'all over 40 minutes post-operative', 'description': 'vomiting , hypotension, bradycardia Vomiting'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ketodex, ketofol , agitation , nasal surgery'], 'conditions': ['Agitation, Emergence']}, 'descriptionModule': {'briefSummary': '* emergence agitation is seen in around 68% after nasal surgeries. Agitated patients needs more staff and nurses to control their abnormal movement which leads to self extubation , removal of catheters and bruises in the extremities.\n* Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to prevent EA . Recently, ketodex is found to reduce the incidence and severity of EA .\n* We aim to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of emergence Agitation in adults undergoing nasal surgeries.', 'detailedDescription': 'The incidence of emergence agitation (EA) after nasal surgeries is relatively high , it is reported to be 68% (1).The precise mechanism is not known. Awake extubation after nasal surgeries is preferred as the airway may be contaminated by blood , and the nasal airway may be blocked by surgical packs that causes sense of suffocation. Awake extubation and nasal pack is a trigger to emergence agitation(2).\n\nemergence agitation (EA) is harmful to the patient and the staff, it Characterized by disorientation, confusion, abnormal violent movement that may result in serious complication and morbidity(3). It develops early with the recovery from general anesthesia(4). Although agitation is more observed in pediatrics but its incidence in adults reach up to 21.4% (5).\n\nDifferent medication agents such as anesthetic drugs, benzodiazepine and α2 agonist was proved to attenuate the EA with different efficiencies (6).\n\nDexmedetomidine is a selective α2 adrenoceptor agonist. It has sedative, hypnotic, anxiolytic, analgesic and sympatholytic properties. It was proved to reduce the EA in children(7). However there was few data about its effect in reducing the agitation in adult after general anesthesia(8).\n\nPropofol is short acting hypnotic and sedative agent. It is used for induction and maintenance of anesthesia(9). Previous studies proved that propofol was effective in preventing EA (10,11) and depends on the time of administration(12).\n\nKetamine is N-methyl- D-asparate receptor antagonist, it has anesthetic, sedative and analgesic effect(13).\n\nKetofol is a combination of low dose ketamine with propofol , it has been used for sedation and analgesia. The effect of this combination was supposed to produce less toxicity compared to each drug alone by decreasing the required doses(14).\n\nKetodex is combined low dose of ketamine and dexmedetomidine, it was used for sedation , this combination decrease some of the pitfalls occurring when use dexmedetomidine as a sole agent(15).\n\nMost EA studies was done in pediatric. To our knowledge there was no previous studies report the effect of bolus dose of ketodex versus ketofol on the incidence and prevention of EA after nasal surgeries in adults. This study aimed to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In adults Undergoing nasal surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient acceptance.\n\n * Both gender.\n * Age (21-60) years old.\n * patient with Body Mass Index (BMI) (25-35kg/m²).\n * American Society of Anesthesiologist (ASA) I / II\n * Adult patient scheduled to elective nasal surgeries\n\nExclusion Criteria:\n\n* \\- Patient with difficult airway (mallampati III,IV).\n* Altered mental status (psychiatric and anxiety disorder).\n* Post traumatic stress disorders.\n* History of allergy to study drugs.\n* Patient on sedative or hypnotic medication.\n* Patients with chronic pain or on painkiller.\n* Patients with severe hepatic or kidney impairment.\n* Patients having a history of thyrotoxicosis, hypertension, cardiac , chest or neurological disease.\n* Patient receiving B agonist.\n* Pregnant or breast feeding female.'}, 'identificationModule': {'nctId': 'NCT04018157', 'briefTitle': 'Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries', 'orgStudyIdInfo': {'id': '5452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketodex', 'description': 'ketamine dexmedetomidine mixture', 'interventionNames': ['Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ketofol', 'description': 'ketamine propofol mixture', 'interventionNames': ['Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'normal saline', 'interventionNames': ['Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"']}], 'interventions': [{'name': '"Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"', 'type': 'DRUG', 'otherNames': ['ketalar', 'precedex', 'diprivan'], 'description': 'patients will receive single intravenous bolus of combination from ketamine 0.5mg/kg and dexmedetomidine 1ug/kg in one syringe diluted in 10 ml 0.9% saline.', 'armGroupLabels': ['ketodex', 'ketofol', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '022/055', 'city': 'Zagazig', 'state': 'Elsharkia', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Olfat Amin, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine, Zagazig university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'olfat abd elmoniem ibrahem', 'investigatorAffiliation': 'Zagazig University'}}}}