Phase 3
N=672
The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
Delirium
Bottom Line
View on ClinicalTrials.gov: NCT01690988 ↗Enrolled (actual)
672
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 — 85; 43 Participants — p=0.912
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketamine (0.5 mg/kg) (Drug); Normal Saline (placebo) (Drug); Ketamine (1 mg/kg) (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 |
85; 43 | 0.912 |
| SECONDARY Daily Maximum Pain Recorded |
70; 63.5; 68; 56; 59; 57.5 | 0.964 |
| SECONDARY Median Opioid Consumption |
88.9; 94.7; 78.7 | 0.476 |
| SECONDARY Number of Patients With Postoperative Nausea and Vomiting |
72; 73; 64 | 0.572 |
| SECONDARY ICU and/or Hospital Length of Stay |
— | — |
| SECONDARY Adverse Outcomes (Number of Patients With Hallucinations) |
45; 40; 62 | 0.01 sig |
| SECONDARY Adverse Outcomes (Number of Patients With Nightmares) |
27; 18; 34 | 0.03 sig |
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01690988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.