Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT04232150
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2020-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Overall, 116 patients were enrolled, out of which 20 were excluded before start of study for the following reasons: contraindication for spinal anesthesia (n=10), preoperative administration of sedative agent (n=3), refusal to be enrolled in study (n=4), a patient with neurological disorder (Schizophrenia), a blind patient, and a deaf patient. Of the 96 patients included, 33 were enrolled in group C, 32 in group S; however, 2 patients requested a deeper level of sedation so an added dose of midazolam and fentanyl were given thus excluding them from study, and 31 patients in group R.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative recall of auditory stimuli and intraoperative noise', 'timeFrame': '4 months', 'description': 'For auditory recall, a question was asked by the surgeon to the patient at maximum stimulation. Patients were examined for auditory recall by following-up the patients postoperatively in the inpatient department.'}, {'measure': 'Postoperative recall of visual stimuli', 'timeFrame': '4 months', 'description': 'For visual recall, a picture of a horse assigned at maximum stimulation, a cat at recovery room, and a bird after discharge to the inpatient department. Patients were examined for visual recall by following-up the patients postoperatively in the inpatient department.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midazolam', 'Orthopedic surgery', 'total knee replacement', 'total hip replacement'], 'conditions': ['Anesthesia', 'Orthopedic Surgery']}, 'descriptionModule': {'briefSummary': "Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.", 'detailedDescription': "Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing total knee or total hip replacement.\n* ASA I, II, or III.\n* patients undergoing spinal anesthesia.\n\nExclusion Criteria:\n\n* patient refusal.\n* \\<24 hours sedative administration.\n* patient with hearing impairment.\n* neurological or memory disorder.\n* abnormal kidney function tests.\n* any contraindication for spinal anesthesia.'}, 'identificationModule': {'nctId': 'NCT04232150', 'briefTitle': 'Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': "Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?", 'orgStudyIdInfo': {'id': '67/2019/865'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group C (control group)', 'description': 'control group will receive no sedation under spinal anesthesia.', 'interventionNames': ['Procedure: spinal anesthesia with no sedation.']}, {'type': 'EXPERIMENTAL', 'label': 'Group O (single dose group)', 'description': 'patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia.', 'interventionNames': ['Drug: single-dose midazolam for sedation under spinal anesthesia.']}, {'type': 'EXPERIMENTAL', 'label': 'Group M (double dose group)', 'description': 'patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia.', 'interventionNames': ['Drug: Double-dose midazolam for sedation under spinal anesthesia.']}], 'interventions': [{'name': 'single-dose midazolam for sedation under spinal anesthesia.', 'type': 'DRUG', 'description': 'Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group O received 0.025mg/kg midazolam at skin incision.', 'armGroupLabels': ['Group O (single dose group)']}, {'name': 'Double-dose midazolam for sedation under spinal anesthesia.', 'type': 'DRUG', 'description': 'Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group M received 0.025mg/kg midazolam at skin incision and repeated 5 minutes before maximum stimulation.', 'armGroupLabels': ['Group M (double dose group)']}, {'name': 'spinal anesthesia with no sedation.', 'type': 'PROCEDURE', 'description': 'Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring.', 'armGroupLabels': ['Group C (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11942', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abdelkarim S. Aloweidi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mahmoud M. Almustafa', 'investigatorAffiliation': 'University of Jordan'}}}}