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Effect of S-ketamine on Postoperative Delirium in Patients undergoing Total Hip or Knee Arthroplasty under Intraspinal Anesthesia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Pragmatic Study

Effect of S-ketamine on Postoperative Delirium in Patients undergoing Total Hip or Knee Arthroplasty under Intraspinal Anesthesia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Pragmatic Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075796
Enrollment
Unknown
Registered
2023-09-15
Start date
2023-09-30
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Postoperative Delirium

Interventions

The intervention group :In the intervention group, subjects will receive an intravenous infusion of S-ketamine following a standard dilution protocol [40mg S-ketamine with 0.9% normal saline to 20ml,
The control group:In the control group, subjects will receive 0.9% saline at 0.1 ml/kg/h. The infusion time was 1 hour, and the mode was constant rate infusion. After surgery, all subjects will be tra

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient age>=60 years old; 2. Selective total hip or knee replacement surgery under spinal anesthesia; 3. Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who were in a state of delirium and suffering from mental illness before the start of the experiment; 2. Patients with contraindications to the use of ketamine (such as allergies, intracranial aneurysms, hyperthyroidism, and glaucoma); 3. Patients with severe cardiovascular diseases (such as Grade III hypertension, unstable angina, severe heart valve disease, severe arrhythmia, and severe macrovascular disease); 4. Patients with severe liver and kidney dysfunction (such as Child Pugh score III, creative clearance rate30 kg/m^2.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the incidence of POD in the first 3 days after surgery;

Secondary

MeasureTime frame
Frequency of positive delirium;The onset time and duration of delirium;Delirium severity score;Subtypes of delirium;Pain scores at rest and exercise;Opioid consumption;The time of first analgesia pump compression within 24 hours after surgery;Preoperative baseline and 3 days post-operative Timed Up and Go test;Active range of motion of the affected knee or hip at preoperative baseline and postoperative day 3 ;Barthel index score is at baseline and at day 3 after surgery;Time to discharge criteria;Length of hospital stay;Sleep quality on postoperative day 1 to 3;

Countries

China

Contacts

Public ContactYang Zhao

The Affiliated Hospital of Qingdao University

zhaoy1979@qdu.edu.cn+86 186 6180 5080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026