Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-07 @ 7:02 AM
Study NCT ID:
NCT05313659
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2022-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramuscular Ketamine Effect on Postnasal Surgery Agitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-15', 'releaseDate': '2025-09-25'}], 'estimatedResultsFirstSubmitDate': '2025-09-25'}}, '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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Agitation', 'timeFrame': 'immediately After extubation.', 'description': 'Using The Richmond agitation-sedation score. The score being from(-5) to (+4) ; 2 and more being agitated patients and less than 2 not agitated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Agitation', 'Emergence', 'Ketamine', 'Intramuscular', 'Nasal surgery'], 'conditions': ['Agitation, Emergence']}, 'descriptionModule': {'briefSummary': 'Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.', 'detailedDescription': 'At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated.\n\nThe EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age group 18-64 years old\n2. ASA I-II\n3. BMI 20-29.9\n4. Patients accepting the study and consenting\n5. Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.\n\nExclusion Criteria:\n\n1. ketamine allergy\n2. Morphine allergy\n3. History of cardiac, neurological, or psychiatric disease, glaucoma,\n4. Patients with a body mass index of less than 20 or more than 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT05313659', 'briefTitle': 'Intramuscular Ketamine Effect on Postnasal Surgery Agitation', 'organization': {'class': 'OTHER', 'fullName': 'Jordanian Royal Medical Services'}, 'officialTitle': 'Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'postoperative agitation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group-K', 'description': 'At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K', 'interventionNames': ['Drug: Ketamine Hydrochloride']}, {'type': 'NO_INTERVENTION', 'label': 'group-S', 'description': 'At the end of surgery and immediately after the inhalational agent was discontinued, 2 mL of normal saline was administered intramuscularly.'}], 'interventions': [{'name': 'Ketamine Hydrochloride', 'type': 'DRUG', 'description': 'intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off', 'armGroupLabels': ['group-K']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11855', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordanian Royal Medical Services', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Husam A. Almajali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordanian Royal Medical Services'}, {'name': 'Ali M. Abu Dalo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordanian Royal Medical Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordanian Royal Medical Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesia specialist', 'investigatorFullName': 'Husam A. Almajali', 'investigatorAffiliation': 'Jordanian Royal Medical Services'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-25', 'type': 'RELEASE'}, {'date': '2025-10-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Husam A. Almajali, anesthesia specialist, Jordanian Royal Medical Services'}}}}