Impact of Closely Grouped, Iterative Exposures to Suxamethonium During ECT on the Sensitization to NMBA and the Development of Protective Antibodies

NCT05210062 | Unknown

• 1 other identifier: APHP210659
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Mania; Hallucinations

Keywords

Electroconvulsive therapy; Depressive disorders; Sensitization; Protective antibodies; Neuro-Muscular Blocking Agents (NMBA); Suxamethonium

Outcome Measures

Primary Outcomes (2)

• Evaluate the development of specific antibodies against suxamethonium (type IgG4 anti-suxamethonium) after iterative exposure to ECT at 10 weeks.

  Development of specific antibodies against suxamethonium

  10 weeks

• Incidence of protective antibodies against suxamethonium assessed by the presence of specific anti-suxamethonium IgG4 antibodies (via ImmunoCAP method) following iterative exposure to ECT after 10 weeks.

  Incidence of protective antibodies against suxamethonium

  10 weeks

Secondary Outcomes (47)

• Evaluate the development of specific IgE antibodies against quaternary ammoniums and suxamethonium after iterative exposure to ECT at 2 weeks.

  2 weeks

• Evaluate the development of specific IgE antibodies against quaternary ammoniums and suxamethonium after iterative exposure to ECT at 4 weeks.

  4 weeks

• Evaluate the development of specific IgE antibodies against quaternary ammoniums and suxamethonium after iterative exposure to ECT at 10 weeks.

  10 weeks

• Evaluate the development of specific IgG antibodies against quaternary ammoniums and suxamethonium after iterative exposure to ECT at 2 weeks.

  2 weeks

• Evaluate the development of specific IgG antibodies against quaternary ammoniums and suxamethonium after iterative exposure to ECT at 4 weeks.

  4 weeks

Study Arms (1)

Exposure to suxamethonium during ECT

A single group is planned in this study, consisting of patients with a medical indication for ECT for psychiatric pathologies which are resistant to medical treatment (depression, mania, hallucinatory episode in particular).

Other: Iterative exposure to suxamethonium during ECT sessions

Interventions

Iterative exposure to suxamethonium during ECT sessions OTHER

The study is divided into 2 phases: phase P and phase E. Phase P: 10 patients to be included in 1 month with a unique dose of suxamethonium during one session of ECT. One blood sample will be taken from patients before their index ECT session. The objective is to evaluate the feasibility of antibody detection relative to the main objective of the study, to ensure the number of patients to include in phase E (analysis in the following month). Depending on the frequency of antibodies detected, particularly IgG4, the number of patients required for phase E will be revised. If no antibodies are detected, the study will be discontinued. Phase E: 60 patients to be included in 12 months with 5 blood samples: before the first session of ECT (S0), at 2 weeks (S2), at 4 weeks (S4), between 6 - 14 weeks (preferably at S10) and at 6 months (M6). Only first-time patients or those not having been exposed to ECT in the past 10 years will be included in this phase.

Exposure to suxamethonium during ECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring ECT for psychiatric pathologies that are resistant to medical treatments (particularly depression, mania, hallucinations). * Phase P (pilot): 10 patients to be included in 1 month with a unique dose. The analysis will be done the following month. The objective is to ennsure the number of patients to include in phase E. * Phase E (study): 60 patients to be included in 12 months (follow-up care until 6 months) with 5 biological samples: before the first exposure to ECT (S0), after 2 weeks (S2), at 4 weeks (S4), between 6 - 14 weeks (S10) and at 6 months (M6). Only patients having exposed to ECT in the past 10 years will be included in this trial. Grouped analysis shall be done at the end of the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint-Antoine Hospital

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Depression; Mania; Hallucinations; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Mood Disorders; Mental Disorders

Study Officials

• Aurélie Gouel

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie Gouel

CONTACT

01 40 25 70 67; aurelie.gouel@aphp.fr

Luc De Chaisemartin

CONTACT

01 40 25 68 97; luc.de-chaisemartin@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: January 27, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-01

Locations

FR (1)