Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05502705
Status:
UNKNOWN
Last Update Posted:
2022-08-16
First Post:
2022-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Intravenous Lidocaine on Postoperative Cognitive Function in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-13', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-08-13', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative cognitive dysfunction (POCD)', 'timeFrame': 'at preoperation,1 and 3 days postoperation', 'description': 'the incidence of POCD'}], 'primaryOutcomes': [{'measure': 'Changes from Baseline BDNF at 1, 3 days after surgery', 'timeFrame': 'at preoperation,1 and 3 days postoperation', 'description': 'Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the BDNF by using Enzyme-linked immunosorbent assay.'}, {'measure': 'Changes from Baseline NGF at 1, 3 days after surgery', 'timeFrame': 'at preoperation,1 and 3 days postoperation', 'description': 'Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the NGF by using Enzyme-linked immunosorbent assay.'}, {'measure': 'Changes from Baseline miRNA-206 at 1, 3 days after surgery', 'timeFrame': 'at preoperation,1 and 3 days postoperation', 'description': 'Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-206 by using PCR.'}, {'measure': 'Changes from Baseline miRNA-98 at 1, 3 days after surgery', 'timeFrame': 'at preoperation,1 and 3 days postoperation', 'description': 'Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-98 by using PCR.'}], 'secondaryOutcomes': [{'measure': 'Changes from Baseline mini-mental state examination (MMSE) at 1, 3 days after surgery', 'timeFrame': 'at preoperation,1 and 3 days postoperation', 'description': 'MMSE was performed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative cognitive dysfunction', 'Lidocaine', 'Brain-derived neurotrophic factor', 'Nerve growth factor', 'miRNA-206', 'miRNA-98'], 'conditions': ['Organ Protection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy of intravenous lidocaine on BDNF, NGF, miRNA-206 and miRNA-98 in serum in elderly patients undergoing abdominal surgery under general anesthesia.', 'detailedDescription': 'Postoperative cognitive dysfunction (POCD) is a major complication following surgeries and anesthesia, especially in elderly individuals. Lidocaine, an inexpensive, widely available, and relatively safe compound, is a local anesthetic that readily crosses the blood-brain barrier. Intravenous lidocaine can reduce the incidence of POCD. However, the mechanism is still unclear.\n\nBrain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF), which are regulated by miRNA-206 and miRNA-98 respectively, play a key role in learning, memory, and cognition. Previous studies have shown that the levels of BDNF and NGF can be improved by lidocaine.\n\nThe objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early POCD, and the levels of BDNF, NGF, miRNA-206 and miRNA-98 in elderly patients undergoing abdominal surgery under general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients were scheduled by following abdominal surgery under general anesthesia\n* Aged 65 - 80 years\n* ASA physical status Ⅱ-Ⅲ\n\nExclusion Criteria:\n\n* Severe heart, pulmonary, hepatic and renal insufficiency\n* History of neurological diseases (including Alzheimer's disease and stroke history)\n* Psychological disorder, and drug or alcohol abuse\n* History of anesthesia and surgery\n* psychiatric illness\n* Unwillingness to comply with the protocol or procedures\n* Allergic to lidocaine\n* Mini-Mental State Examination (MMSE) score\\<23 before surgery"}, 'identificationModule': {'nctId': 'NCT05502705', 'briefTitle': 'The Effect of Intravenous Lidocaine on Postoperative Cognitive Function in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Effects of Intravenous Lidocaine on Serum BDNF, NGF, miRNA-206 and miRNA-98 in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia', 'orgStudyIdInfo': {'id': 'Yujingfang202201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the first hour, 1.5 mg/kg for the second hour, 0.7 mg/kg until the end of the surgery.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.', 'interventionNames': ['Other: Normal saline (NS)']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the frst hour, 1.5 mg/kg for the second hour, 0.7 mg/kg until the end of the surgery', 'armGroupLabels': ['Lidocaine']}, {'name': 'Normal saline (NS)', 'type': 'OTHER', 'description': 'Patients are received equal volumes of saline intravenously until the end of the surgery', 'armGroupLabels': ['Normal saline']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}