Postoperative DeliriumEarly Phase 1SKEDNCT05242692
The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-cardiac Thoracic Surgery
A Early Phase 1 study testing S-ketamine and Dexmedetomidine in people with Postoperative Delirium and Elderly Patients, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Postoperative Delirium, Elderly Patients
- What is being tested?
- S-ketamine and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 31 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer hospital and institute of Guangzhou medical university
Guangzhou, Guangdong, 510095
About this study
Official title: 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, Positive-controlled, Non-inferiority Trial
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.
Read the 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 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. Secondary outcomes included postoperative delirium severity, motroic subtypes, episodes, and duration. Additional prespecified outcomes were emergence delirium; time to delirium onset; time to extubation; postoperative pain intensity at rest and during cough at 4, 24, and 48 h postoperatively; postoperative opioid consumption and rescue analgesia requirements; subjective sleep quality within the initial 4 days after surgery; postoperative length of hospital stay; and cognitive function and mortality at 30- and 90-day follow-up.
- Conditions
- Postoperative Delirium, Elderly Patients
- Being tested
- S-ketamine, Dexmedetomidine
- Keywords
- Postoperative delirium, S-ketamine, Dexmedetomidine, elderly patients
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamineDrug
Loading dose: 0.25mg/kg in 10 minutes Maintenance dose: 0.1mg/kg/h
DexmedetomidineDrug
Loading dose: 0.2 ug/kg in 10 minutes Maintenance dose: 0.2 ug/kg/h
| Study group | Role | What they receive |
|---|---|---|
| S-ketamine | Experimental | S-ketamine (50 mg, 2 ml) is diluted to 50 ml (1 mg/ml) with 48 ml normal saline; Receives: Drug: S-ketamine |
| Dexmedetomidine | Active comparator | Dexmedetomidine (200 ug, 2 ml) is diluted to 100 ml (2 ug/ml) with 98 ml normal saline; Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Post-operative Delirium in 4 Days After Surgery
3-minute Diagnostic Confusion Assessment Method (3D-CAM)
Measured: Within 4 days after surgery
Secondary outcomes (2)
Severity of Delirium
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)
Measured: Within 4 days after surgery
Duration of postoperative delirium
Positive days of postoperative delirium
Measured: Within 4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start10 Jun 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yihua Li, PhD, Study chair, Cancer hospital and institute of Guangzhou medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242692
- Sponsor's protocol ID
- ATHGuangzhou
- Acronym
- SKED
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35914911
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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, Positive-controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05242692
- Acronym / sponsor ID
- SKED / ATHGuangzhou
- Conditions
- Postoperative Delirium, Elderly Patients
- Keywords
- Postoperative delirium, S-ketamine, Dexmedetomidine, elderly patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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. Secondary outcomes included postoperative delirium severity, motroic subtypes, episodes, and duration. Additional prespecified outcomes were emergence delirium; time to delirium onset; time to extubation; postoperative pain intensity at rest and during cough at 4, 24, and 48 h postoperatively; postoperative opioid consumption and rescue analgesia requirements; subjective sleep quality within the initial 4 days after surgery; postoperative length of hospital stay; and cognitive function and mortality at 30- and 90-day follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-ketamine | Experimental | Drug: S-ketamineS-ketamine (50 mg, 2 ml) is diluted to 50 ml (1 mg/ml) with 48 ml normal saline; |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineDexmedetomidine (200 ug, 2 ml) is diluted to 100 ml (2 ug/ml) with 98 ml normal saline; |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-ketamineLoading dose: 0.25mg/kg in 10 minutes Maintenance dose: 0.1mg/kg/h | Drug | S-ketamine |
| DexmedetomidineLoading dose: 0.2 ug/kg in 10 minutes Maintenance dose: 0.2 ug/kg/h | Drug | Dexmedetomidine |
Primary outcome
Number of Patients With Post-operative Delirium in 4 Days After Surgery
Time frame: Within 4 days after surgery
3-minute Diagnostic Confusion Assessment Method (3D-CAM)
2 secondary outcomes
Severity of Delirium
Time frame: Within 4 days after surgery
Duration of postoperative delirium
Time frame: Within 4 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 35914911Wei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yihua Li, PhD study chair
Cancer hospital and institute of Guangzhou medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing S-ketamine and Dexmedetomidine in people with Postoperative Delirium and Elderly Patients, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Post-operative Delirium in 4 Days After Surgery (time frame: Within 4 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.