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Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial.
Trials 2018; 19(1):326T

Abstract

BACKGROUND

Postoperative delirium is common in elderly cardiac surgery patients. It is multifactorial and is influenced by the patient's baseline status and the nature of the medical and surgical interventions that the patient receives. Some of these factors are potentially modifiable, including postoperative sedation and analgesia protocols. This study has been designed to evaluate the effectiveness of postoperative intravenous acetaminophen in conjunction with either dexmedetomidine or propofol in decreasing the incidence of delirium.

METHODS

This is a prospective, randomized, placebo-controlled, double-blinded, factorial trial that includes patients who are at least 60 years old and who are undergoing cardiac surgeries involving cardiopulmonary bypass, including coronary artery bypass graft (CABG) and combined CABG/valve surgeries. Patients are randomly assigned to receive one of four postoperative analgesic-sedation regimens: (1) acetaminophen and dexmedetomidine, (2) acetaminophen and propofol, (3) dexmedetomidine and placebo, or (4) propofol and placebo. The primary outcome, incidence of delirium, will be assessed with the Confusion Assessment Method (CAM or CAM-ICU). The secondary outcome, postoperative cognitive decline, will be assessed with the Montreal Cognitive Assessment. Additional secondary outcomes, including duration of delirium, postoperative analgesic requirement, length of stay, and incidence of adverse events, will also be reported. Data will be analyzed in 120 randomly assigned patients who received at least one dose of the study medication(s) on a modified intention-to-treat basis.

DISCUSSION

This study has been approved by the institutional review board at Beth Israel Deaconess Medical Center, and the trial is currently recruiting. This study will systematically examine the implications of modification in postoperative sedative/analgesic protocols after cardiac surgery, specifically for short- and long-term cognitive outcomes. Any positive outcomes from this study could direct simple yet effective practice changes aimed to reduce morbidity.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02546765 , registered January 13, 2015.

Authors+Show Affiliations

Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA.Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA. Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA.Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA.Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA.Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA. Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA. Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA. Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road, CC-650, Boston, MA, 02215, USA. bsubrama@bidmc.harvard.edu. Harvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA. bsubrama@bidmc.harvard.edu.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29929533

Citation

Shankar, Puja, et al. "Dexmedetomidine and Intravenous Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery (DEXACET Trial): Protocol for a Prospective Randomized Controlled Trial." Trials, vol. 19, no. 1, 2018, p. 326.
Shankar P, Mueller A, Packiasabapathy S, et al. Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial. Trials. 2018;19(1):326.
Shankar, P., Mueller, A., Packiasabapathy, S., Gasangwa, D., Patxot, M., O'Gara, B., ... Subramaniam, B. (2018). Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial. Trials, 19(1), p. 326. doi:10.1186/s13063-018-2718-0.
Shankar P, et al. Dexmedetomidine and Intravenous Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery (DEXACET Trial): Protocol for a Prospective Randomized Controlled Trial. Trials. 2018 Jun 22;19(1):326. PubMed PMID: 29929533.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial. AU - Shankar,Puja, AU - Mueller,Ariel, AU - Packiasabapathy,Senthil, AU - Gasangwa,Doris, AU - Patxot,Melissa, AU - O'Gara,Brian, AU - Shaefi,Shahzad, AU - Marcantonio,Edward R, AU - Subramaniam,Balachundhar, Y1 - 2018/06/22/ PY - 2018/01/23/received PY - 2018/06/01/accepted PY - 2018/6/23/entrez PY - 2018/6/23/pubmed PY - 2019/3/15/medline KW - Acetaminophen KW - Cardiac surgery KW - Confusion Assessment Method KW - Coronary artery bypass grafting KW - Dexmedetomidine KW - Montreal Cognitive Assessment KW - Neurocognition KW - Postoperative delirium KW - Propofol SP - 326 EP - 326 JF - Trials JO - Trials VL - 19 IS - 1 N2 - BACKGROUND: Postoperative delirium is common in elderly cardiac surgery patients. It is multifactorial and is influenced by the patient's baseline status and the nature of the medical and surgical interventions that the patient receives. Some of these factors are potentially modifiable, including postoperative sedation and analgesia protocols. This study has been designed to evaluate the effectiveness of postoperative intravenous acetaminophen in conjunction with either dexmedetomidine or propofol in decreasing the incidence of delirium. METHODS: This is a prospective, randomized, placebo-controlled, double-blinded, factorial trial that includes patients who are at least 60 years old and who are undergoing cardiac surgeries involving cardiopulmonary bypass, including coronary artery bypass graft (CABG) and combined CABG/valve surgeries. Patients are randomly assigned to receive one of four postoperative analgesic-sedation regimens: (1) acetaminophen and dexmedetomidine, (2) acetaminophen and propofol, (3) dexmedetomidine and placebo, or (4) propofol and placebo. The primary outcome, incidence of delirium, will be assessed with the Confusion Assessment Method (CAM or CAM-ICU). The secondary outcome, postoperative cognitive decline, will be assessed with the Montreal Cognitive Assessment. Additional secondary outcomes, including duration of delirium, postoperative analgesic requirement, length of stay, and incidence of adverse events, will also be reported. Data will be analyzed in 120 randomly assigned patients who received at least one dose of the study medication(s) on a modified intention-to-treat basis. DISCUSSION: This study has been approved by the institutional review board at Beth Israel Deaconess Medical Center, and the trial is currently recruiting. This study will systematically examine the implications of modification in postoperative sedative/analgesic protocols after cardiac surgery, specifically for short- and long-term cognitive outcomes. Any positive outcomes from this study could direct simple yet effective practice changes aimed to reduce morbidity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02546765 , registered January 13, 2015. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29929533/Dexmedetomidine_and_intravenous_acetaminophen_for_the_prevention_of_postoperative_delirium_following_cardiac_surgery__DEXACET_trial_:_protocol_for_a_prospective_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2718-0 DB - PRIME DP - Unbound Medicine ER -