The Effect of Ramelteon on Postoperative Delirium in Elderly Patients: A Randomised Double-Blind Study

Gupta, Prabhat K.; Verma, Reetu; Kohli, Monica; Shukla, Nidhi; Kannaujia, Shashank

doi:10.7860/jcdr/2019/42635.13384

Cited by 7 publications

(9 citation statements)

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“…One study included patients from a variety of surgical specialties. 30 Mean patient age was above 50 for all studies and several studies used a minimum age as an exclusion criterion.…”

Section: Resultsmentioning

confidence: 99%

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Does melatonin administration reduce the incidence of postoperative delirium in adults? Systematic review and meta-analysis

et al. 2023

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Postoperative delirium (POD) is common. It is associated with increased morbidity and mortality. Many cases may be preventable and melatonin offers promise as a preventative agent.ObjectiveThis systematic review provides an up-to-date synthesis of the evidence on the effect of melatonin in preventing POD.DesignA systematic search of randomised controlled trials of melatonin in POD was run across multiple databases (EMBASE, MEDLINE, CINAHL, PsycINFO) and a clinical trials registry (ClinicalTrials.org) (1 January 1990 to 5 April 2022). Studies examining the effects of melatonin on POD incidence in adults are included. Risk of bias was assessed using the Cochrane risk of bias 2 tool.Outcome measuresThe primary outcome is POD incidence. Secondary outcomes are POD duration and length of hospital stay. Data synthesis was undertaken using a random-effects meta-analysis and presented using forest plots. A summary of methodology and outcome measures in included studies is also presented.ResultsEleven studies, with 1244 patients from a range of surgical specialties were included. Seven studies used melatonin, in variable doses, and four used ramelteon. Eight different diagnostic tools were used to diagnose POD. Time points for assessment also varied. Six studies were assessed as low risk of bias and five as some concern. The combined OR of developing POD in the melatonin groups versus control was 0.41 (95% CI 0.21 to 0.80, p=0.01).ConclusionThis review found that melatonin may reduce the incidence of POD in adults undergoing surgery. However, included studies displayed inconsistency in their methodology and outcome reporting. Further work to determine the optimum regime for melatonin administration, along with consensus of how best to evaluate results, would be beneficial.PROSPERO registration numberCRD42021285019.

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“…One study included patients from a variety of surgical specialties. 30 Mean patient age was above 50 for all studies and several studies used a minimum age as an exclusion criterion.…”

Section: Resultsmentioning

confidence: 99%

“…The studies included patients across a range of surgical specialties, including general, orthopaedic and cardiothoracic surgery. One study included patients from a variety of surgical specialties 30. Mean patient age was above 50 for all studies and several studies used a minimum age as an exclusion criterion.…”

Section: Resultsmentioning

confidence: 99%

Does melatonin administration reduce the incidence of postoperative delirium in adults? Systematic review and meta-analysis

et al. 2023

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“…Finally, eight blinded RCTs with 587 participants were included (Table 1). 9,14–16,19–22 A flowchart of the search strategy is shown in Figure 1. The complete search strategies (Supporting Information: Appendix ) and reasons for exclusion (Supporting Information: Appendix ) are shown in the Supporting Information.…”

Section: Resultsmentioning

confidence: 99%

“…In our analysis, single or double doses of ramelteon administration were not significantly associated with lower odds of delirium occurrence. Notably, participants in the three RCTs 14,15,19 in the non‐multiple‐dose group were all surgical patients. The precipitating factors of delirium in surgical patients may continue for a long period of time, such as postoperative pain, withdrawal from anesthetics, inflammation, anemia due to blood loss, or hypoactivity that may not resolve in a short duration 28 .…”

Section: Discussionmentioning

confidence: 99%

“…The subgroup analyses showed that a lower odds of delirium occurrence was observed in the elderly group (k = 5; OR: 0.28; 95% CI; 0.09−0.85; I 2 = 27.93%; Q = 5.13; p = .27) but not in the non-elderly group (k = 3; OR: 0.64; 95% CI: 0.37−1.10; I 2 = 7.45%; Q = 2.16; p = .34) (Supporting Information: eFigure 7), and the group difference was not significant (p = . 19). In addition, a lower odds of delirium occurrence was observed in the multiple dosage group (k = 5; OR: 0.34; 95% CI: 0.14−0.82; I 2 = 44.24%; Q = 6.33; p = .18) but not in the non-multiple dosage group (k = 3; OR: 0.79; 95% CI: 0.33−1.86; I 2 = 0%; Q = 1.84; p = .40) (Supporting Information: eFigure 8), and the group difference was not significant (p = .18).…”

Section: Subgroup Analyses For Primary Outcomementioning

confidence: 99%

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Ramelteon for delirium prevention in hospitalized patients: An updated meta‐analysis and trial sequential analysis of randomized controlled trials

Carvalho

Thompson

et al. 2023

Journal of Pineal Research

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Although ramelteon has been examined as a relatively new therapeutic option for delirium prevention, current evidence to evaluate its efficacy is limited. We conducted an updated meta‐analysis and examine the reliability of existing evidence regarding the effect of ramelteon on delirium prevention in hospitalized patients. Seven major electronic databases were systematically searched to identify randomized controlled trials examining the efficacy of ramelteon in delirium prevention. Data were pooled using a frequentist‐restricted maximum‐likelihood random‐effects model. A trial sequential analysis was performed using relative risk reduction thresholds of 50%. The primary outcome was the incidence of delirium (reported as odds ratio with 95% confidence intervals). The secondary outcomes were the days of delirium, all‐cause mortality, and all‐cause discontinuation. Of 187 potentially eligible studies identified, 8 placebo‐controlled randomized controlled trials (n = 587) were included. This updated meta‐analysis showed that ramelteon was associated with lower odds of delirium occurrence than placebo (0.50; 0.29−0.86; I2 = 17.48%). In trial sequential analysis, the effect of ramelteon across the superiority boundary when using a relative risk reduction threshold ranging from 40% to 60%. In subgroup analyses, ramelteon compared with placebo was associated with lower odds of delirium occurrence in the elderly group (k = 5; 0.28; 0.09−0.85; I2 = 27.93%) and multiple dosage group (k = 5; 0.34; 0.14−0.82; I2 = 44.24%) but not in the non‐elderly and non‐multiple dosage groups. When considering surgical patients and medical patients separately, ramelteon showed a trend in the treatment of delirium prevention in both groups, while these findings were not statistically significant. No significant between‐group differences were found in the secondary outcomes. The current meta‐analysis provides updated and reliable evidence that ramelteon, in comparison with placebo, reduces the risk of delirium among hospitalized patients.

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Prophylactic effect of exogenous melatonin and melatonin receptor agonists on postoperative delirium in elderly patients: a systemic review and meta-analysis of randomized controlled trials

Jiang,

lai,

Chen

et al. 2023

Aging Clin Exp Res

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The Effect of Ramelteon on Postoperative Delirium in Elderly Patients: A Randomised Double-Blind Study

Cited by 7 publications

References 0 publications

Does melatonin administration reduce the incidence of postoperative delirium in adults? Systematic review and meta-analysis

Does melatonin administration reduce the incidence of postoperative delirium in adults? Systematic review and meta-analysis

Ramelteon for delirium prevention in hospitalized patients: An updated meta‐analysis and trial sequential analysis of randomized controlled trials

Prophylactic effect of exogenous melatonin and melatonin receptor agonists on postoperative delirium in elderly patients: a systemic review and meta-analysis of randomized controlled trials

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