Trial reportBMC neurology2012
Transdermal rotigotine for the perioperative management of restless legs syndrome.
Trial report in BMC neurology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00498186 (An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome), which is not on this map. Cited by 4 papers.
What it found
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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.
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.
An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Who cites it
4 citing papers in PubMed.
- Translation from Preclinical Research to Clinical Trials: Transdermal Drug Delivery for Neurodegenerative and Mental Disorders.Pharmaceutical research · 2024Review
- Exacerbation of restless legs syndrome following amygdalohippocampectomy: A case report.PCN reports : psychiatry and clinical neurosciences · 2024Article
- Central Disorders of Hypersomnolence, Restless Legs Syndrome, and Surgery With General Anesthesia: Patient Perceptions.Frontiers in human neuroscience · 2018Article
- [Perioperative approach to restless legs syndrome].Der Anaesthesist · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImmobilisation, blood loss, sleep deficiency, and (concomitant) medications during perioperative periods might lead to acute exacerbation of symptoms in patients with the restless legs syndrome (RLS). Continuous transdermal delivery of the dopamine agonist rotigotine provides stable plasma levels over 24 h and may provide RLS patients with a feasible treatment option for perioperative situations. To assess the feasibility of use of rotigotine transdermal patch for the perioperative management of moderate to severe RLS, long-term data of an open-label extension of a rotigotine dose-finding study were retrospectively reviewed.
methodsThe data of all 295 patients who had entered the 5-year study were screened independently by two reviewers for the occurrence of surgical interventions during the study period. The following data were included in this post-hoc analysis: patient age, sex, surgical intervention and outcome, duration of hospital stay, rotigotine maintenance dose at the time of surgery, rotigotine dose adjustment, and continuation/discontinuation of rotigotine treatment. All parameters were analysed descriptively. No pre-specified efficacy assessments (e.g. IRLS scores) were available for the perioperative period.
resultsDuring the study period, 61 surgical interventions were reported for 52 patients (median age, 63 years; 67% female); the majority of patients (85%) had one surgical intervention. The mean rotigotine maintenance dose at time of surgery was 3.1 ± 1.1 mg/24 h. For most interventions (95%), rotigotine dosing regimens were maintained during the perioperative period. Administration was temporarily suspended in one patient and permanently discontinued in another two. The majority (96%) of the patients undergoing surgery remained in the study following the perioperative period and 30 of these patients (61%) completed the 5-year study.
conclusionsAlthough the data were obtained from a study which was not designed to assess rotigotine use in the perioperative setting, this post-hoc analysis suggests that treatment with rotigotine transdermal patch can be maintained during the perioperative period in the majority of patients and may allow for uninterrupted alleviation of RLS symptoms.
trial registrationThe 5-year rotigotine extension study is registered with ClinicalTrials.gov, identifier NCT00498186.
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