Informations générales (source: ClinicalTrials.gov)

NCT05210062 Statut inconnu
Impact of Closely Grouped, Iterative Exposures to Suxamethonium During Electroconvulsive Therapy (ECT) on the Sensitization to Neuro-Muscular Blocking Agents (NMBA) and the Development of Protective Antibodies
Observational
  • Hallucinations
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
janvier 2022
septembre 2023
12 septembre 2025
Acute per-anesthetic hypersensitivity reaction (HSA-PA) is a rapidly occurring systemic reaction following injection of a drug during anesthesia (mortality between 3 and 9%). The substances responsible for these reactions in France are Neuro-Muscular Blocking Agents (NMBA) in 60% of cases. The main mechanism mentioned is an immediate systemic hypersensitivity immune reaction (anaphylaxis). The mechanism of immunization to NMBA is not yet understood. Electroconvulsive therapy (ECT) is a long-standing therapeutic approach still widely used today, for its high efficiency, particularly in depressive syndromes resistant to antidepressants. It has an efficacy comparable (or even superior) to pharmacological treatments and improves the mortality associated with this disease. Treatment with iterative ECT sessions includes an attack phase with an average of 12 sessions over 4 weeks, with secondary spacing of sessions before switching to antidepressant treatment. These sessions are carried out in the operating room under general anesthesia, thanks to a hypnotic and a NMBA, suxamethonium, as recently recommended by the French Anesthesiology Society in 2020. ECT therefore represent an interesting model of iterative exposure of a relatively homogeneous population to a single highly sensitizing substance, which could make it possible to study the evolution of sensitization as a function of various factors, in particular cumulative exposure, for which no data is currently available.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
GHU PARIS PSY ET NEUROSCIENCES GOUEL Aurélie En recrutement IDF 01/11/2025 07:52:50  Contacter
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 01/11/2025 07:52:52  Contacter
AP-HP - Hôpital Bicêtre
AP-HP - Hôpital Bichat
AP-HP - Hôpital La Pitié-Salpêtrière
AP-HP - Hôpital Lariboisiere-Fernand Widal
AP-HP - Hôpital Louis Mourier
AP-HP - Hôpital Saint Antoine

Critères

Tous
Inclusion Criteria:

- Patient requiring iterative exposure to ECT as part of their psychiatric pathology
in one of the investigator center

- Patient who has not had ECT in the last 10 years for the phase E group, regardless
of their previous ECT exposure for the phase P group

- Patient who has been informed and has signed the consent form



- Absence of written informed consent

- Allergies identified specifically to Neuro-Muscular Blocking Agents (NMBA)

- Patient under tutelage, curatorship or judicial protection

- Patient without social security

- Contraindication to ECT : intracranial hypertension, intracranial lesions without
intracranial hypertension, recent episode of cerebral hemorrhage, recent myocardial
infarction or embologenic disease, presence of aneurysms or vascular malformations
at risk of hemorrhage, retinal detachment, pheochromocytoma, history of ineffective
treatment with ECT having had serious side effects, taking anticoagulant treatments