Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT06564506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1460}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative delirium within the first three postoperative days', 'timeFrame': 'At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days', 'description': 'The incidence of POD within the first three postoperative days will be assessed using the Confusion Assessment Method (CAM). The CAM evaluates four diagnostic features: (1) acute onset or fluctuating course, (2) inattention, (3) disorganised thinking and (4) altered consciousness. Delirium is diagnosed when features 1 and 2 are present, with either 3 or 4. Blinded investigators will assess for POD at least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days.'}], 'secondaryOutcomes': [{'measure': 'Delirium severity', 'timeFrame': 'At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days', 'description': 'Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity'}, {'measure': 'Delirium subtypes', 'timeFrame': 'At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days', 'description': 'Richmond Agitation Sedation Scale (RASS); hypoactive (-3 to 0), hyperactive (+1 to +4) or mixed'}, {'measure': 'Cognitive function', 'timeFrame': 'At 1, 3, 6 and 12 months postoperatively', 'description': 'Abbreviated Mental Test Score (AMTS) via telephone at 1, 3, 6 and 12 months postoperatively'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Assessed preoperatively and daily for three days postoperatively', 'description': 'Hospital Anxiety and Depression Scale (HADS); 14-item checklist (7 for anxiety, 7 for depression); each item scored 0-3; total score \\>8 suggests mild disorder, \\>10 moderate disorder'}, {'measure': 'Postoperative pain', 'timeFrame': 'Assessed at 1, 3, 6, 12, 24, 36, 48, 60 and 72 hours postsurgery', 'description': '11-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at rest and movement'}, {'measure': 'Postoperative morphine consumption', 'timeFrame': 'During 72 hours postsurgery', 'description': 'Cumulative morphine use and rescue analgesia recorded over 72 hours postsurgery'}, {'measure': 'Recovery quality', 'timeFrame': 'Assessed daily for three days postoperatively', 'description': 'Chinese version of the 15-item Quality of Recovery Questionnaire (QoR-15); range 0-150, higher scores indicate better recovery'}, {'measure': 'Sleep quality', 'timeFrame': 'Assessed preoperatively and daily for three days postoperatively', 'description': 'Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep'}, {'measure': 'Adverse events', 'timeFrame': 'through study completion, an average of 7 days', 'description': 'Any adverse events during the study will be documented on the electronic medical records'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Older adults', 'Electroacupuncture', 'Postoperative delirium', 'Total knee arthroplasty'], 'conditions': ['Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'Electroacupuncture may improve cognitive function and altered consciousness, but its effect on postoperative delirium in older arthroplasty patients remains unexplored. This study aims to assess the efficacy of electroacupuncture in preventing postoperative delirium in older adults undergoing total knee arthroplasty.', 'detailedDescription': 'Electroacupuncture combines traditional acupuncture with electrical stimulation at specific body points. Recent clinical studies have shown promising results for acupuncture-related techniques in managing perioperative neurocognitive disorders. However, the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty remains unexplored.This randomised controlled trial aims to evaluate the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65-90 years\n* American Society of Anaesthesiologists (ASA) physical status class II or III\n* Scheduled for elective unilateral total knee arthroplasty under general anesthesia\n\nExclusion Criteria:\n\n* Baseline dementia or Mini-Mental State Examination (MMSE) score below 24\n* Implanted electrical devices (eg, pacemakers, brain or spinal cord neurostimulator)\n* Infection or abscess at any selected acupuncture point\n* Severe hematopoietic or hemorrhagic disease\n* Severe audio-visual impairments or inability to communicate in Mandarin\n* Alcohol or illicit drug misuse disorder\n* Current use of sedatives, antidepressants or glucocorticoids\n* Received acupuncture or electroacupuncture within one month before surgery\n* Any condition deemed unsafe or unsuitable by the research team'}, 'identificationModule': {'nctId': 'NCT06564506', 'briefTitle': 'Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty: a Multicentre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'K2023-02-004/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active electroacupuncture group', 'description': 'Participants will receive 30 minutes of active electroacupuncture before anaesthesia induction. Experienced acupuncturists will administer electroacupuncture at Shenting (GV24, 0.5 cun \\[≈10 mm\\] above the anterior hairline midpoint) and bilateral Benshen (GB13, 3 cun \\[≈60 mm\\] lateral to GV24). After skin preparation and pad placement, patients will close their eyes. Needles will be inserted 20 to 24 mm into the subgaleal layer at a flat angle, then manually manipulated to elicit de qi sensations (eg, fullness, numbness and soreness). Electrodes attached to the needle handles will deliver stimulation for 30 minutes (2 Hz/15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.', 'interventionNames': ['Device: Disposable acupuncture needles (0.30 × 75 mm)', 'Device: SDZ-V electroacupuncture devices']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham electroacupuncture group', 'description': 'Participants will receive 30 minutes of sham electroacupuncture before anaesthesia induction.The sham group will use non-acupuncture points: 20 mm above GV24 and 20 mm lateral to GB13. These points, in different dermatomes from true acupoints, minimise location-specific effects. The procedure will match the active group, excluding needle manipulation, de qi sensation and electrical output.', 'interventionNames': ['Device: Placebo needles (0.30 × 25 mm)', 'Device: SDZ-V electroacupuncture devices']}], 'interventions': [{'name': 'Disposable acupuncture needles (0.30 × 75 mm)', 'type': 'DEVICE', 'description': 'Disposable acupuncture needles (0.30 × 75 mm), placebo needles (0.30 × 25 mm) and SDZ-V electroacupuncture devices (Hwato, Suzhou Medical Supplies Factory Co Ltd, China) will be used. Electrodes attached to the needle handles will deliver stimulation for 30 minutes (2 Hz/15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.', 'armGroupLabels': ['Active electroacupuncture group']}, {'name': 'Placebo needles (0.30 × 25 mm)', 'type': 'DEVICE', 'description': 'Disposable acupuncture needles (0.30 × 75 mm), placebo needles (0.30 × 25 mm) and SDZ-V electroacupuncture devices (Hwato, Suzhou Medical Supplies Factory Co Ltd, China) will be used. Sham electroacupuncture will use blunt-tipped placebo needles without current output, which retract into their handles to simulate skin insertion.', 'armGroupLabels': ['Sham electroacupuncture group']}, {'name': 'SDZ-V electroacupuncture devices', 'type': 'DEVICE', 'description': 'Disposable acupuncture needles (0.30 × 75 mm), placebo needles (0.30 × 25 mm) and SDZ-V electroacupuncture devices (Hwato, Suzhou Medical Supplies Factory Co Ltd, China) will be used. Electrodes attached to the needle handles will deliver stimulation for 30 minutes (2 Hz/15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.', 'armGroupLabels': ['Active electroacupuncture group', 'Sham electroacupuncture group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Yusheng Yao, MD', 'role': 'CONTACT', 'email': 'fjslyys@126.com', 'phone': '+86-13559939629'}], 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Yusheng Yao, MD', 'role': 'CONTACT', 'email': 'fjslyys@126.com', 'phone': '+86-13559939629'}], 'overallOfficials': [{'name': 'Yusheng Yao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Provincial Hospital, China'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'from 3 months after publication, until 5 years.', 'ipdSharing': 'YES', 'description': 'The individual deidentified participant data, the study protocol, and the statistical analysis plan can be accessed from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yao Yusheng', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}