Evidence map›Paper›PMID 39998812›Full record

Trial reportMedicine2025

Melatonin for preventing postoperative delirium in elderly patients: A multicenter randomized placebo-controlled pilot study.

Maram Khaled, Jason Chui, Joycelyne Ewusie, John Agzarian, Jessica Bogach, Maria Gomez, Bobby Shayegan, Yaron Shargall, Nawar Alkhamesi, James Paul and 2 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. 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

12 authors.

Maram KhaledDepartment of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
Jason ChuiDepartment of Anesthesia and Perioperative Medicine, Western University, University Hospital, London, Ontario, Canada.
Joycelyne EwusieDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
John AgzarianDepartment of Surgery, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
Jessica BogachDepartment of Surgery, McMaster University, Institute for Applied Health Sciences (4th Floor), Hamilton, Ontario, Canada.
Maria GomezDepartment of Anesthesia and Perioperative Medicine, Western University, University Hospital, London, Ontario, Canada.
Bobby ShayeganDepartment of Surgery, McMaster University, Institute for Applied Health Sciences (4th Floor), Hamilton, Ontario, Canada.
Yaron ShargallDepartment of Surgery, McMaster University, Institute for Applied Health Sciences (4th Floor), Hamilton, Ontario, Canada.
Nawar AlkhamesiDepartment of Surgery, Western University, 268 Grosvenor Street, St. Joseph's Hospital Rm. E3-118, London, Ontario, Canada.
James PaulDepartment of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Harsha ShanthannaDepartment of Anesthesia, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0002-4105-4465

Funding

Hamilton Academic Health Sciences Organization, St. Joseph’s Healthcare Hamilton Collaboration grant
6 · The paper itself

Abstract

backgroundPostoperative delirium (POD) in older adults is associated with high risk of morbidity and mortality. With limited treatment options, prevention is essential. Melatonin has been suggested to prevent delirium through regulating the sleep-wake cycle and serotonin metabolism, which has been shown to be disrupted in patients with POD. However, the evidence regarding the use of melatonin for POD prevention is limited and inconclusive.

methodsOur multicenter, 2-arm, parallel-group, feasibility randomized controlled trial evaluated the effect of melatonin on POD incidence after noncardiac surgery in patients >65 years (n = 120). Patients were randomized to 3 mg oral melatonin or placebo once preoperatively and for 7 days postoperatively. Patients were assessed twice daily for delirium and followed at 3 months postoperatively. Feasibility outcomes were recruitment rate, medication adherence, and proportion completing 3-month follow-up. Clinical outcomes were delirium incidence, sleep quality, institutional discharge, and cognitive status at 3 months.

resultsBetween September 2021 and June 2023, 85 patients were randomized (~1 patient/wk); of these, 92.9% adhered to study medications and 87.1% completed the 3-month follow-up. POD occurred in 9 patients with no statistical difference between the groups (melatonin group, n = 7; placebo group, n = 2; adjusted odds ratio: 1.12; 95% confidence interval: 0.006-150.1). There were no differences in any other clinical outcomes. Pandemic-related challenges, including interruption of surgeries and restrictions on research procedures impacted feasibility and the study was terminated early due to futility.

conclusionsBased on our observations, a sample size of >1000 patients is required for a definitive trial to evaluate the role of melatonin in reducing the incidence of POD. Design changes need to be considered to address feasibility challenges and ongoing post-pandemic modifications to patient care.

Indexed as

DeliriumMelatoninPostoperative ComplicationsAgedAged, 80 and overDouble-Blind MethodFeasibility StudiesFemaleHumansIncidenceMalePilot ProjectsSleep QualityMelatonin

Identifiers

PMID39998812
PMCPMC11856979

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.