The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
- Conditions
- DeliriumCognitive DisordersAcute Kidney Injury
- Interventions
- Registration Number
- NCT02554253
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia as well as as an analgesic. It has been shown to have anti-inflammatory properties which may decrease post-operative complications following cardiac surgery with cardiopulmonary bypass that are thought to associated with inflammation. Some studies have shown that ketamine does decrease these complications when compared with anesthetics that are not commonly used in our cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication which is used for induction of anesthesia. Ketamine has not been compared with propofol for potential to reduce post-operative complications associated with the inflammatory process. This study aims to see if ketamine will reduce the incidence of cognitive dysfunction, delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic impact of ketamine compared propofol will be investigated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketamine Ketamine Ketamine induction Propofol Propofol Propofol induction
- Primary Outcome Measures
Name Time Method Number of Patients With Postoperative Cognitive Dysfunction Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. Pre and postoperative cognitive studies will be performed to assess change in cognitive function.
Postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests. The neurocognitive tests utilized include Trail making Test A, Trail making Test B, Hopkins Verbal Learning Test-Revised Learning trials, Hopkins Verbal Learning Test-Revised Delayed Recall, Digit Span, Controlled Oral Word Association Test, Stroop color/word test, and the Mini Mental Status Examination.
- Secondary Outcome Measures
Name Time Method Number of Patients With Acute Kidney Injury Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. AKI was defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria including an increase in serum creatinine ≥0.3 mg/dL within 48 hours, an increase in serum creatinine to ≥1.5 times baseline within 7 days, and urine output \< 0.5 mL/kg/hr for 6 hours.
Number of Patients Who Develop Postoperative Delirium Baseline (preoperative cognitive tests) to hospital discharge or 10 days postoperatively whichever came first. Delirium was defined as a positive CAM (Confusion assessment method) score. CAM score was recorded every 12 hours postoperatively as per routine. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4. The score is either positive or negative. Positive means the patient has delirium and negative indicates the patient is not delirious.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States