CompletedEarly Phase 1

The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-cardiac Thoracic Surgery

China520 participantsStarted 2022-06-10

Plain-language 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 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.

Who can participate

Age range

60 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With Post-operative Delirium in 4 Days After Surgery

Timeframe: Within 4 days after surgery

Trial details

NCT IDNCT05242692

SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Postoperative Delirium trials