Confusion after noncardiac surgery

Effect of low-dose ketamine on postoperative delirium in patients undergoing noncardiac surgery: a pilot study. - Ketamine and postoperative delirium.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000956-16-NL

Enrollment

250

Registered

2013-07-11

Start date

2013-07-15

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

To investigate the clinical use of Ketamine for the prevention of postoperative delirium in patients undergoing noncardiac surgery.

Interventions

Trade Name: Ketanest-S 5 Product Name: Ketanest S 5 Product Code: RVG 22550 Pharmaceutical Form: Injection Trade Name: SodiumChloride 0.9% Product Name: SodiumChloride 0.9% Product Code: RVG27512 Pha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • The patient has provided written informed consent. • Age = 65 years. • The patient is planned for hip or knee replacement surgery or major/peripheral vascular surgery under general anesthesia, with a scheduled duration of more than one hour and a minimal hospitalization of three days. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: • The patient has severe systemic disease that limits activity and is a constant threat to life (ASA IV). • The patient has an acute psychiatric disorder. • The patient has an active infection and/or fever is present. • The patient has a history of hypersensitivity to one of the study drugs. • The patient has a MMSE score below 24 points. • Prolonged sedation after surgery for more than 24 hours is anticipated. • The patient has a history of poorly/uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Main Objective: Prevention of postoperative delirium.;Secondary Objective: Secondary goals include blood levels of specified biomarkers that are associated with a delirium.;Primary end point(s): The main study endpoint is the incidence of postoperative delirum within the first three postoperative days.;Timepoint(s) of evaluation of this end point: within 3 days of surgery	—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints include blood levels of specified biomarkers that are associated with a delirium.;Timepoint(s) of evaluation of this end point: within 3 days of surgery	—

Countries

Netherlands

Contacts

Public ContactDepartment of Anesthesiology

Erasmus Medical Center

f.vanlier@erasmusmc.nl+31 107040704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026