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

NCT05242692 | Completed Early Phase 1 DMC

• 1 other identifier: ATHGuangzhou
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Postoperative Delirium; Elderly Patients

Keywords

Postoperative delirium; S-ketamine; Dexmedetomidine; elderly patients

Outcome Measures

Primary Outcomes (1)

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

  3-minute Diagnostic Confusion Assessment Method (3D-CAM)

  Within 4 days after surgery

Secondary Outcomes (2)

• Severity of Delirium

  Within 4 days after surgery

• Duration of postoperative delirium

  Within 4 days after surgery

Other Outcomes (14)

• Emergence delirium

  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

• Pain severity

  Within 2 days after surgery

• Quality of sleep

  Within 4 days after surgery

Study Arms (2)

S-ketamine

EXPERIMENTAL

S-ketamine (50 mg, 2 ml) is diluted to 50 ml (1 mg/ml) with 48 ml normal saline;

Drug: S-ketamine

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine (200 ug, 2 ml) is diluted to 100 ml (2 ug/ml) with 98 ml normal saline;

Drug: Dexmedetomidine

Interventions

S-ketamine DRUG

Loading dose: 0.25mg/kg in 10 minutes Maintenance dose: 0.1mg/kg/h

S-ketamine

Dexmedetomidine DRUG

Loading dose: 0.2 ug/kg in 10 minutes Maintenance dose: 0.2 ug/kg/h

Dexmedetomidine

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Cancer hospital and institute of Guangzhou medical university

Guangzhou, Guangdong, 510095, China

Location

Related Publications (1)

• 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.

  PMID: 35914911 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Esketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yihua Li, PhD

  Cancer hospital and institute of Guangzhou medical university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 16, 2022
• Study Start: June 10, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)