| Title: |
Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy. |
| Authors: |
Jaiswal, Stuti J; Vyas, Anuja D; Heisel, Andrew J; Ackula, Haritha; Aggarwal, Ashna; Kim, Nick H; Kerr, Kim M; Madani, Michael; Pretorius, Victor; Auger, William R; Fernandes, Timothy M; Malhotra, Atul; Owens, Robert L |
| Source: |
Critical Care Medicine, vol 47, iss 12 |
| Publisher Information: |
eScholarship, University of California |
| Publication Year: |
2019 |
| Collection: |
University of California: eScholarship |
| Subject Terms: |
32 Biomedical and Clinical Sciences (for-2020); 3202 Clinical Sciences (for-2020); 42 Health Sciences (for-2020); Mental Health (rcdc); Neurosciences (rcdc); Prevention (rcdc); Clinical Research (rcdc); Patient Safety (rcdc); Clinical Trials and Supportive Activities (rcdc); Neurodegenerative (rcdc); Acquired Cognitive Impairment (rcdc); Brain Disorders (rcdc); 6.1 Pharmaceuticals (hrcs-rac); 3 Good Health and Well Being (sdg); Adult (mesh); Aged (mesh); Delirium (mesh); Double-Blind Method (mesh); Elective Surgical Procedures (mesh); Endarterectomy (mesh); Female (mesh); Humans (mesh); Indenes (mesh); Male (mesh); Middle Aged (mesh); Postoperative Complications (mesh); delirium; melatonin receptor agonists; ramelteon; sleep |
| Time: |
1751 - 1758 |
| Description: |
OBJECTIVES: To assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the perioperative, ICU setting. DESIGN: Parallel-arm, randomized, double-blinded, placebo-controlled trial. SETTING: Academic medical center in La Jolla, California. PATIENTS: Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy. INTERVENTIONS: Ramelteon 8 mg or matching placebo starting the night prior to surgery and for a maximum of six nights while in the ICU. MEASUREMENTS AND MAIN RESULTS: Incident delirium was measured twice daily using the Confusion Assessment Method-ICU. The safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale. One-hundred twenty participants were enrolled and analysis completed in 117. Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516). Delirium duration, as assessed by the number of delirium-free days was also similar in both groups (placebo median 2 d [interquartile range, 2-3 d] vs ramelteon 3 d [2-5 d]; p = 0.181). Coma-free days was also similar between groups (placebo median 2 d [interquartile range, 1-3 d] vs ramelteon 3 d [2-4 d]; p = 0.210). We found no difference in ICU length of stay (median 4 d [interquartile range, 3-5 d] vs 4 d [3-6 d]; p = 0.349), or in-hospital mortality (four vs three deaths; relative risk ratio, 0.7; 95% CI, 0.2-3.2; p = 0.717), all placebo versus ramelteon, respectively. CONCLUSIONS: Ramelteon 8 mg did not prevent postoperative delirium in patients admitted for elective cardiac surgery. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
qt3ch0m5tk; https://escholarship.org/uc/item/3ch0m5tk; https://escholarship.org/content/qt3ch0m5tk/qt3ch0m5tk.pdf |
| DOI: |
10.1097/ccm.0000000000004004 |
| Availability: |
https://escholarship.org/uc/item/3ch0m5tk; https://escholarship.org/content/qt3ch0m5tk/qt3ch0m5tk.pdf; https://doi.org/10.1097/ccm.0000000000004004 |
| Rights: |
public |
| Accession Number: |
edsbas.ACB35D33 |
| Database: |
BASE |