Evidence map›Paper›PMID 29929533›Full record

ArticleTrials2018

Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial.

Puja Shankar, Ariel Mueller, Senthil Packiasabapathy, Doris Gasangwa, Melissa Patxot, Brian O'Gara, Shahzad Shaefi, Edward R Marcantonio, Balachundhar Subramaniam

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02546765 (Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery in Adult Patients 60 Years of Age and Older), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02546765 phase4completednot on this map

Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery in Adult Patients 60 Years of Age and Older

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2015 to 2019Enrolled140ConditionsDeliriumArmsIV acetaminophen & IV propofol, IV acetaminophen & IV dexmedetomidine, IV propofol & placebo, IV dexmedetomidine & placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Article
  3. The effect of thoracic epidural analgesia on short-term outcome and mortality in geriatric patients undergoing open heart surgery.Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES · 2022
    Article
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Puja ShankarCenter 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.
Ariel MuellerCenter 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.
Senthil PackiasabapathyCenter 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.
Doris GasangwaCenter 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.
Melissa PatxotCenter 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.
Brian O'GaraCenter 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.
Shahzad ShaefiCenter 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.
Edward R MarcantonioHarvard Medical School, 25 Shattuck Street, Boston, MA, 02215, USA.
Balachundhar SubramaniamCenter 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.
Beth Israel Deaconess Medical Center · USLemuel Shattuck Hospital · USHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative 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.

methodsThis 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 registrationClinicalTrials.gov Identifier: NCT02546765 , registered January 13, 2015.

Indexed as

AcetaminophenAdministration, IntravenousAnalgesics, Non-NarcoticBostonCardiac Surgical ProceduresCardiopulmonary BypassCognitionCoronary Artery BypassDeliriumDexmedetomidineDouble-Blind MethodDrug Administration ScheduleHeart Valve Prosthesis ImplantationHumansHypnotics and SedativesLength of StayAcetaminophenAnalgesics, Non-NarcoticDexmedetomidineHypnotics and SedativesPropofolAcetaminophenCardiac surgeryConfusion Assessment MethodCoronary artery bypass graftingDexmedetomidineMontreal Cognitive AssessmentNeurocognitionPostoperative deliriumPropofol

Identifiers

PMID29929533
PMCPMC6013954
OpenAlexW2808960992

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.