Status:
COMPLETED
The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-cardiac Thoracic Surgery
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions:
Postoperative Delirium
Elderly Patients
Eligibility:
All Genders
60-90 years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Aged 60 years or over
- Both genders
- American anesthesiologist association (ASA) physical status classificationⅠ-Ⅲ
- Diagnosed with lung, esophagus, or mediastinum disorders
- Undergoing open or video-assisted thoracic surgery including lobectomy, segmentectomy, pneumonectomy, esophagectomy, or resection of mediastinal tumor
- General anesthesia with one-lung ventilation (OLV) or bronchial blocker.
- An expected operation duration of 2 hours or more.
- Voluntarily participate in the trial and sign informed consent.
Exclusion
- History of psychiatric disease or severe depression
- History of glaucoma or hyperthyroidism
- History of severe hepatic (Child-Pugh grade C) or renal (requirement for renal replacement therapy) disorder.
- Body mass index (BMI) greater 35 kg/m2
- Dementia history or baseline Mini-Mental State Examination (MMSE) score less than 23
- Severe audio-visual impairments, or inability to speak Mandarin or Cantonese precluding communication
- Sinus bradycardia (heart rate \< 50 beats per minutes, bpm), sick sinus or Wolff- Parkinson-White syndromes, or Ⅱ degree atrioventricular block and over
- Poorly controlled hypertension (resting systolic blood pressure over 180 mm Hg, or resting diastolic blood pressure over 100 mm Hg)
- Allergic to dexmedetomidine, S-ketamine or any of their formulation ingredients;
- Taking sedatives, antidepressants or glucocorticoids
- Alcohol or drug abuser
- Life expectancy of less than 2 months due to extensive tumor metastasis.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT05242692
Start Date
March 10 2022
End Date
August 31 2025
Last Update
October 2 2025
Active Locations (1)
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1
Cancer hospital and institute of Guangzhou medical university
Guangzhou, Guangdong, China, 510095