The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 6/7/2018 |
| Start Date: | February 1, 2014 |
| End Date: | July 2017 |
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).
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).
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 postoperative complications, including delirium, pain, opioid
consumption, and nausea and vomiting. Low dose ketamine would be particularly appealing as a
drug to prevent delirium and other postoperative 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, with the possibility of
conducting a larger randomized clinical trial pending the results of this study. At the time
of enrollment, patients will undergo the same delirium and pain evaluation that will be used
postoperatively. Additionally patients will be screened for functional dependence using the
Barthel Index of Activities of Daily Living, for depression using the Geriatric Depression
Scale - Short Form, and for obstructive sleep apnea using the STOP-Bang criteria. They will
also be asked about any falls they have experienced in the six months prior to surgery.
Comorbid conditions, including the components of the Charlson Comorbidity Index, will be
obtained by reviewing the patients' medical records. Any available preoperative lab results,
including electrolytes and blood counts, will also be recorded.
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 on the
afternoon/evening of postoperative day 0 (if feasible) and twice daily (morning and
afternoon/evening with at least six hours between assessments) on postoperative days 1-3
using the Confusion Assessment Method or the Confusion Assessment Method for Intensive Care
Unit. Acute pain will be assessed via the observer-based Behavioral Pain Scale or Behavioral
Pain Scale (Non-Intubated) with subsequent administration of the patient-reported Visual
Analog Scale from postoperative days 0-3. Postoperative opioid consumption will be assessed
from the patients' medical charts for postoperative days 0-3. Postoperative nausea and
vomiting will be assessed via a patient-reported section of the Behavioral Pain Scale or
Behavioral Pain Scale (Non-Intubated) for postoperative days 0-3. ICU and/or hospital length
of stay will be assessed from the patients' medical charts. Adverse outcomes (e.g.
hallucinations and nightmares) will be assessed via the Confusion Assessment Method or the
Confusion Assessment Method for Intensive Care Unit for postoperative days 0-3.
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 postoperative complications, including delirium, pain, opioid
consumption, and nausea and vomiting. Low dose ketamine would be particularly appealing as a
drug to prevent delirium and other postoperative 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, with the possibility of
conducting a larger randomized clinical trial pending the results of this study. At the time
of enrollment, patients will undergo the same delirium and pain evaluation that will be used
postoperatively. Additionally patients will be screened for functional dependence using the
Barthel Index of Activities of Daily Living, for depression using the Geriatric Depression
Scale - Short Form, and for obstructive sleep apnea using the STOP-Bang criteria. They will
also be asked about any falls they have experienced in the six months prior to surgery.
Comorbid conditions, including the components of the Charlson Comorbidity Index, will be
obtained by reviewing the patients' medical records. Any available preoperative lab results,
including electrolytes and blood counts, will also be recorded.
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 on the
afternoon/evening of postoperative day 0 (if feasible) and twice daily (morning and
afternoon/evening with at least six hours between assessments) on postoperative days 1-3
using the Confusion Assessment Method or the Confusion Assessment Method for Intensive Care
Unit. Acute pain will be assessed via the observer-based Behavioral Pain Scale or Behavioral
Pain Scale (Non-Intubated) with subsequent administration of the patient-reported Visual
Analog Scale from postoperative days 0-3. Postoperative opioid consumption will be assessed
from the patients' medical charts for postoperative days 0-3. Postoperative nausea and
vomiting will be assessed via a patient-reported section of the Behavioral Pain Scale or
Behavioral Pain Scale (Non-Intubated) for postoperative days 0-3. ICU and/or hospital length
of stay will be assessed from the patients' medical charts. Adverse outcomes (e.g.
hallucinations and nightmares) will be assessed via the Confusion Assessment Method or the
Confusion Assessment Method for Intensive Care Unit for postoperative days 0-3.
Inclusion Criteria:
- Patients 60 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)
- Unable to provide informed consent
- Patients with drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine,
methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin)
- Patients taking anti-psychotic medications (e.g., chlorpromazine, clozapine,
olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone,
amisulpride, sertindole)
- Patients with a weight outside the range 50 kg - 200 kg (110 lbs - 440 lbs)
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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