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Effect of S-Ketamine Intervention Regimen on Postoperative Delirium in Elderly Patients Undergoing Non-Cardiac Surgery: A Multicenter, Prospective, Randomized, Triple-Blind, Pragmatic Study Protocol

Effect of S-Ketamine Intervention Regimen on Postoperative Delirium in Elderly Patients Undergoing Non-Cardiac Surgery: A Multicenter, Prospective, Randomized, Triple-Blind, Pragmatic Study Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122271
Enrollment
Unknown
Registered
2026-04-10
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Interventions

Single Bolus Group (SB):The SB group received a 30-minute infusion of placebo (normal saline) prior to the start of surgery
during induction of anesthesia, S-ketamine was administered as a single intravenous bolus of 0.2 mg/kg within 30 - 60 seconds after all induction drug infusions had been completed.Placebo (normal sali
Single Bolus plus Intraoperative Continuous Infusion Group (SBCI):The SBCI group received a 30-minute infusion of placebo (normal saline) prior to the start of surgery
during induction of anesthesia, S-ketamine was administered as a single intravenous bolus of 0.2 mg/kg within 30 - 60 seconds after all induction drug infusions had been completed. S-ketamine was infu
Preoperative Pre-infusion plus Postoperative Continuous Infusion Group (PICI):The PICI group received S-ketamine 0.1 mg/kg prior to the start of surgery, infused over 30 minutes (equivalent to 0.2 mg/

Sponsors

The Affiliated Hospital of Qingdao UniversityThe Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 60 years. 2.Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration of at least 2 hours (e.g., gastrointestinal surgery, hepatobiliary and pancreatic surgery, otorhinolaryngologic surgery, lower limb joint arthroplasty, spinal surgery, thoracic surgery, urologic surgery, gynecologic surgery). 3.Planned use of patient-controlled intravenous analgesia (PCA) for postoperative pain management. 4.Provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pre-existing delirium state or psychotic disorder at time of screening. 2.Known contraindications to S-ketamine: documented allergy or hypersensitivity; intracranial aneurysm; uncontrolled hyperthyroidism; glaucoma. 3.Severe cardiovascular disease: grade III hypertension, unstable angina pectoris, severe valvular heart disease, severe arrhythmia (e.g., uncontrolled atrial fibrillation), or severe macrovascular disease. 4.Severe hepatic or renal impairment: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2N upper limit of normal; hyperbilirubinemia; prothrombin time = 3.

Design outcomes

Primary

MeasureTime frame
The incidence of POD;

Secondary

MeasureTime frame
Frequency of delirium;The onset time of delirium;The duration of delirium;Delirium severity score;Subtypes of delirium;Pain scores at rest and exercise;Opioid consumption;Sleep quality score;Quality of recovery score;

Countries

China

Contacts

Public ContactLei Zhang

The Affiliated Hospital of Qingdao University

weiymzhl@126.com+86 82919395

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026