Evidence map›Paper›PMID 31567351›Full record

Trial reportCritical care medicine2019

Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy.

Stuti J Jaiswal, Anuja D Vyas, Andrew J Heisel, Haritha Ackula, Ashna Aggarwal, Nick H Kim, Kim M Kerr, Michael Madani, Victor Pretorius, William R Auger and 3 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Critical care medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 9 pooled it
4.5field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 9 syntheses or guidelines pooled it, 66 citations in OpenAlex.

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  14. Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial.The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2021
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  20. Melatonin and Melatonin Agonists for Prevention of Delirium in the Cardiac Surgical ICU: A Meta-analysis.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

Stuti J JaiswalScripps Research Translational Institute, La Jolla, CA.
Anuja D VyasDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Andrew J HeiselDivision of Hospital Medicine, Scripps Clinic/Scripps Green Hospital, La Jolla, CA.
Haritha AckulaDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Ashna AggarwalScripps Research Translational Institute, La Jolla, CA.
Nick H KimDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Kim M KerrDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Michael MadaniDivision of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.
Victor PretoriusDivision of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.
William R AugerDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Timothy M FernandesDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Atul MalhotraDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Robert L OwensDivision of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.
Scripps Research Institute · US

Funding

Scripps Translational Science InstituteUL1TR001114 · NCATS · SCRIPPS RESEARCH INSTITUTE, THE · PI TOPOL, ERIC JEFFREY · 2013 to 2017
$24.0M
Scripps Translational Science InstituteKL2TR001112 · NCATS · SCRIPPS RESEARCH INSTITUTE, THE · PI TOPOL, ERIC JEFFREY · 2013 to 2017
$3.0M
NCATS NIH HHS KL2 TR001112NCATS NIH HHS UL1 TR001114
6 · The paper itself

Abstract

objectivesTo assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the perioperative, ICU setting.

designParallel-arm, randomized, double-blinded, placebo-controlled trial.

settingAcademic medical center in La Jolla, California. PATIENTS: Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy.

interventionsRamelteon 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

resultsIncident 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.

conclusionsRamelteon 8 mg did not prevent postoperative delirium in patients admitted for elective cardiac surgery.

Indexed as

EndarterectomyAdultAgedDeliriumDouble-Blind MethodElective Surgical ProceduresFemaleHumansIndenesMaleMiddle AgedPostoperative ComplicationsIndenesramelteon

Identifiers

PMID31567351
PMCPMC6861685
OpenAlexW2973418685

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.