The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial (PODCAST)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 65 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 pain, feelings of depression and feelings of stress after surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Delirium |
Drug: Ketamine Drug: Normal Saline Drug: Ketamine1 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial |
- Incidence of postoperative delirium [ Time Frame: Within three days of surgery ] [ Designated as safety issue: No ]According to Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit criteria
- Postoperative Acute Pain [ Time Frame: Within three postoperative days ] [ Designated as safety issue: No ]Assessed by visual analog pain scale
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ketamine
Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
|
Drug: Ketamine
Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
Other Name: Ketalar
|
|
Placebo Comparator: Normal saline
Intravenous normal saline
|
Drug: Normal Saline
Normal saline IV following induction of anesthesia or administration of sedative medications
Other Name: Normal saline
|
|
Experimental: Ketamine1
Low dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
|
Drug: Ketamine1
Low dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
Other Name: Ketalar
|
Detailed Description:
Postoperative delirium is one of the most common complications of major surgery, affecting between 10% and 70% of all elderly surgical patients. Delirium manifests as poor attention and inability to think logically, and is associated with longer intensive care unit and hospital stay, long lasting cognitive deterioration, and increased mortality rate. Studies have shown that a low sub-anesthetic dose of ketamine, an anesthetic drug, has the potential to decrease several neurological complications, including delirium, pain, depression and posttraumatic stress disorder. Low dose ketamine would be particularly appealing as a drug to prevent delirium and other neurological complications, as it is inexpensive and extremely safe. However, these proposed benefits of ketamine in the perioperative setting have not yet been tested in a large clinical trial. The investigators are therefore proposing a pragmatic, exploratory clinical trial to support or refute the contention that low dose ketamine decreases the incidence of postoperative delirium. Patients will be randomized to receive low dose ketamine or placebo following induction of anesthesia and prior to surgical incision. Blinded observers will assess delirium postoperatively twice daily using the Confusion Assessment Method. Pain scores with a visual analog scale will also be assessed postoperatively.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients 65 and older
- Competent to provide informed consent
- Undergoing major surgery (e.g., open cardiac surgery, open or thoracoscopic thoracic surgery, abdominal surgery, open urological surgery, open gynecological surgery, major orthopedic surgery, major vascular surgery including endovascular procedures, major ear, nose and throat surgery).
Exclusion Criteria:
- Patients with an allergy to ketamine
- Those in whom a significant elevation of blood pressure would constitute a serious hazard (e.g., pheochromocytoma, aortic dissection)
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | Not yet recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Michael Avidan, MD 314-747-4155 avidanm@anest.wustl.edu | |
| Principal Investigator: Michael Avidan, MD | |
| Principal Investigator: | George A Mashour, MD PhD | University of Michigan |
| Study Director: | Daniel A Emmert, MD PhD | Washington University in St. Louis |
| Study Director: | Kane Pryor, MBBS | Cornell |
| Study Director: | Eric Jacobsohn, MB ChB | University of Manitoba |
| Study Director: | Judith Hudetz, PhD | Medical College of Wisconsin |
| Study Chair: | Hilary P Grocott, MD | University of Manitoba |
| Principal Investigator: | Michael S Avidan, MBBCh | Washington University in St. Louis |
More Information
No publications provided
| Responsible Party: | Michael Avidan, Director, Institute of Quality Improvement, Research & Informatics, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01690988 History of Changes |
| Other Study ID Numbers: | 201206071 |
| Study First Received: | August 7, 2012 |
| Last Updated: | May 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Delirium ketamine surgery neurological complications |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Anesthetics Ketamine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013