Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT05242692
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2021-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-cardiac Thoracic Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-01', 'size': 255304, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-25T21:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The labeled "Study medication" syringes (50ml) in identical appearance, and the infusion regimen formulated by the pharmacist based on the randomization, will be distributed to the attending anesthesiologists responsible for anesthetic management as soon as the research team informs the central pharmacy about the patient heading for surgery. To avoid anesthesiologists\' speculation about the randomized assignment, the study drugs will be infused at a similar rate. The anesthesiologists, the patients, the investigators responsible for follow-up, and the statisticians are all masked to randomized allocations until the final statistical analyses are completed. The blindness will be unmasked by the primary investigator in a medical emergency including deterioration of patient\'s condition intraoperatively or adverse events postoperatively.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2021-12-23', 'studyFirstSubmitQcDate': '2022-02-15', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Emergency delirium', 'timeFrame': 'From 30 minutes after the arrival in the post anesthesia care unit (PACU) until the time-point of PACU discharge, assessed up to 2 hours', 'description': 'Richard Agitation-Sedation Scale (RASS) (RASS score ≥ 1 indicates emergency delirium, the higher scores mean a worse outcome.)'}, {'measure': 'Pain severity', 'timeFrame': 'Within 2 days after surgery', 'description': 'Numeric rating scale (NRS)0 = \\[no pain\\], 0 \\< NRS \\< 4 \\[mild pain\\], 4 ≤ NRS \\< 7 \\[moderate pain\\], 7 ≤ NRS \\<10 \\[severe pain\\], NRS = 10 \\[worst pain imaginable\\]'}, {'measure': 'Quality of sleep', 'timeFrame': 'Within 4 days after surgery', 'description': 'Numeric rating scale(0 = best-quality sleep, 10 = worst-quality sleep)'}, {'measure': 'Cognitive function', 'timeFrame': 'On postoperative day 30', 'description': 'Telephone interview for cognitive status-40 (TICS-40); A score below 21 will be defined as mild cognitive impairment, the higher scores mean a worse outcome.'}, {'measure': 'Cognitive function', 'timeFrame': 'On postoperative day 90', 'description': 'Telephone interview for cognitive status-40 (TICS-40); A score below 21 will be defined as mild cognitive impairment, the higher scores mean a worse outcome.'}], 'primaryOutcomes': [{'measure': 'Number of Patients With Post-operative Delirium in 4 Days After Surgery', 'timeFrame': 'Within 4 days after surgery', 'description': '3-minute Diagnostic Confusion Assessment Method (3D-CAM)'}], 'secondaryOutcomes': [{'measure': 'Severity of Delirium', 'timeFrame': 'Within 4 days after surgery', 'description': 'Confusion Assessment Method- Severity (CAM-S, Mild-to-moderate delirium will be defined as a CAM-S score of 3 to 5, while severe delirium will be defined as a CAM-S score of 6 to 7)'}, {'measure': 'Duration of postoperative delirium', 'timeFrame': 'Within 4 days after surgery', 'description': 'Positive days of postoperative delirium'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative delirium', 'S-ketamine', 'Dexmedetomidine', 'elderly patients'], 'conditions': ['Postoperative Delirium', 'Elderly Patients']}, 'referencesModule': {'references': [{'pmid': '35914911', 'type': 'DERIVED', 'citation': 'Wei W, Zhang A, Liu L, Zheng X, Tang C, Zhou M, Gu Y, Yao Y. Effects of subanaesthetic S-ketamine on postoperative delirium and cognitive function in elderly patients undergoing non-cardiac thoracic surgery: a protocol for a randomised, double-blinded, placebo-controlled and positive-controlled, non-inferiority trial (SKED trial). BMJ Open. 2022 Aug 1;12(8):e061535. doi: 10.1136/bmjopen-2022-061535.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative delirium (POD) is a common and distressing complication after thoracic surgery. S-ketamine has neuroprotective properties as a dissociative anesthetic. Emerging literature has indicated that S-ketamine can reduce cognitive impairment in depressed patients. However, the role of S-ketamine in preventing postoperative delirium is still unknown. Therefore, this study aims to evaluate the effect of intraoperatively prophylactic S-ketamine compared to dexmedetomidine on the incidence of postoperative delirium in elderly patients undergoing non-cardiac thoracic surgery.', 'detailedDescription': 'Postoperative delirium (POD) is a common and distressing complication after thoracic surgery. S-ketamine has neuroprotective properties as a dissociative anesthetic. Emerging literature has indicated that S-ketamine can reduce cognitive impairment in depressed patients. However, the role of S-ketamine in preventing postoperative delirium is still unknown. Therefore, this study aims to evaluate the effect of intraoperatively prophylactic S-ketamine compared to dexmedetomidine on the incidence of postoperative delirium in elderly patients undergoing non-cardiac thoracic surgery. This will be a randomized, double-blinded, placebo-and positive-controlled, non-inferiority trial that enrolls patients aged 60 or over undergoing thoracic surgery. The primary outcome will be the incidence of postoperative delirium within 4 days after surgery and assessed using a 3-minute Diagnostic Confusion Assessment Method (3D-CAM) twice a day. The main secondary outcomes will be the severity and duration of postoperative delirium. Other prespecified secondary outcomes will be the incidence of emergency delirium, postoperative pain, quality of sleep, cognitive function, and the plasm concentration of acetylcholine, brain-derived neurotrophic factor, and tumor necrosis factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60 years or over\n* Both genders\n* American anesthesiologist association (ASA) physical status classificationⅠ-Ⅲ\n* Diagnosed with lung, esophagus, or mediastinum disorders\n* Undergoing open or video-assisted thoracic surgery including lobectomy, segmentectomy, pneumonectomy, esophagectomy, or resection of mediastinal tumor\n* General anesthesia with one-lung ventilation (OLV) or bronchial blocker.\n* An expected operation duration of 2 hours or more.\n* Voluntarily participate in the trial and sign informed consent.\n\nExclusion Criteria:\n\n* History of psychiatric disease or severe depression\n* History of glaucoma or hyperthyroidism\n* History of severe hepatic (Child-Pugh grade C) or renal (requirement for renal replacement therapy) disorder.\n* Body mass index (BMI) greater 35 kg/m2\n* Dementia history or baseline Mini-Mental State Examination (MMSE) score less than 23\n* Severe audio-visual impairments, or inability to speak Mandarin or Cantonese precluding communication\n* Sinus bradycardia (heart rate \\< 50 beats per minutes, bpm), sick sinus or Wolff- Parkinson-White syndromes, or Ⅱ degree atrioventricular block and over\n* Poorly controlled hypertension (resting systolic blood pressure over 180 mm Hg, or resting diastolic blood pressure over 100 mm Hg)\n* Allergic to dexmedetomidine, S-ketamine or any of their formulation ingredients;\n* Taking sedatives, antidepressants or glucocorticoids\n* Alcohol or drug abuser\n* Life expectancy of less than 2 months due to extensive tumor metastasis.'}, 'identificationModule': {'nctId': 'NCT05242692', 'acronym': 'SKED', 'briefTitle': 'The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-cardiac Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University'}, 'officialTitle': 'The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-cardiac Thoracic Surgery: a Protocol for Randomized, Double-blinded, placebo-and Positive-controlled, Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'ATHGuangzhou'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-ketamine', 'description': 'S-ketamine (50 mg, 2 ml) is diluted to 50 ml (1 mg/ml) with 48 ml normal saline;', 'interventionNames': ['Drug: S-ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Dexmedetomidine (200 ug, 2 ml) is diluted to 100 ml (2 ug/ml) with 98 ml normal saline;', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'S-ketamine', 'type': 'DRUG', 'description': 'Loading dose: 0.25mg/kg in 10 minutes Maintenance dose: 0.1mg/kg/h', 'armGroupLabels': ['S-ketamine']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Loading dose: 0.2 ug/kg in 10 minutes Maintenance dose: 0.2 ug/kg/h', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Cancer hospital and institute of Guangzhou medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yihua Li, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cancer hospital and institute of Guangzhou medical university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}