Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04908605
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2021-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078785', 'term': 'Mirtazapine'}, {'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-05-27', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of patients with the Riker sedation-agitation score ≥5', 'timeFrame': '24 hours postoperatively', 'description': 'Total number of patients with the Riker sedation-agitation score ≥5'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Agitation']}, 'descriptionModule': {'briefSummary': 'Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation.\n\nMelatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults.\n\nMirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.\n2. Patients according to Mallampati classification I or II.\n3. Patients accepting the study and consenting.\n4. Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.\n5. Body mass index(BMI)\\<30\n\nExclusion Criteria:\n\n1. Patient's refusal.\n2. Known allergy to any of the study medications.\n3. History of obstructive sleep apnea.\n4. History of psychiatric illness or intake of antipsychotics.\n5. History of liver impairment.\n6. Pregnancy.\n7. History of uncontrolled hypertension.\n8. History of renal disease.\n9. Body mass index (BMI) ≥30 kg/m2.\n10. Contraceptive drugs."}, 'identificationModule': {'nctId': 'NCT04908605', 'briefTitle': 'Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine', 'orgStudyIdInfo': {'id': 'FMASU MS251 /202l'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mirtazapine group (Group I) (n=55)', 'interventionNames': ['Drug: Mirtazapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin group (Group II) (n=55)', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group (Group III) (n=55)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mirtazapine', 'type': 'DRUG', 'description': 'Every patient will be given mirtazapine 30 mg tablet', 'armGroupLabels': ['Mirtazapine group (Group I) (n=55)']}, {'name': 'Melatonin', 'type': 'DRUG', 'description': 'Every patient will be given melatonin 5 mg tablet', 'armGroupLabels': ['Melatonin group (Group II) (n=55)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Every patient will be given a matching placebo tablet', 'armGroupLabels': ['Placebo group (Group III) (n=55)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain-Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.', 'investigatorFullName': 'Dr.Ibrahim Mamdouh Esmat', 'investigatorAffiliation': 'Ain Shams University'}}}}