The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial

Summary

Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease the chance that patients will experience delirium after their surgery. The investigators are also testing whether ketamine decreases postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length of stay, and adverse outcomes (e.g. hallucinations and nightmares).

Conditions

• Delirium

Interventions

DRUG

Ketamine (0.5 mg/kg)

Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.

DRUG

Normal Saline (placebo)

Normal saline IV following induction of anesthesia or administration of sedative medications

DRUG

Ketamine (1 mg/kg)

Low dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.

Sponsors & Collaborators

• Asan Medical Center

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• University of Bern

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Virginia Mason Hospital/Medical Center

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• George A Mashour, MD PhD · University of Michigan

• Daniel A Emmert, MD PhD · Washington University School of Medicine

• Kane Pryor, MBBS · Cornell

• Eric Jacobsohn, MB ChB · University of Manitoba

• Judith Hudetz, PhD · Medical College of Wisconsin

• Hilary P Grocott, MD · University of Manitoba

• Michael S Avidan, MBBCh · Washington University School of Medicine

• Sharon Inouye · Harvard Medical School (HMS and HSDM)

• Robert Veselis · Memorial Sloan Kettering Medical Center

• Jayant Aveek · Post Graduate Institute of Medical Education and Research, Chandigarh

• Heiko Kaiser · University of Bern

• Stephen Choi · University of Toronto

• Ryan Pong · Virginia Mason Medical Center

• Gyujeong Noh · Asan Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-01

Primary Completion

2016-06-26

Completion

2017-07-31

Countries

• United States

Study Locations