Confusion after noncardiac surgery

Conditions: To investigate the clinical use of Ketamine for the prevention ofpostoperative delirium in patients undergoing noncardiac surgery.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-000956-16-NL

Lead Sponsor: Erasmus Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 250

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

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints include blood levels of specified biomarkers that<br>are associated with a delirium.;Timepoint(s) of evaluation of this end point: within 3 days of surgery