Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus

NCT05830864 | Completed

• 1 other identifier: MIR-2023-01
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 4

Brief Summary

Isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. The aim of the study is to assess the efficiency of Isoflurane in this indication.

Conditions

Refractory Status Epilepticus

Keywords

Isoflurane

Outcome Measures

Primary Outcomes (1)

• rate of crisis control

  rate of patients with crisis control or complete awakening

  3 months

Study Arms (1)

Main cohort

Adult patients with refractory status epilepticus treated by Isoflurane as third anticonvulsive therapy

Drug: Isoflurane

Interventions

Isoflurane DRUG

no other intervention

Main cohort

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

All patients with eligibility criteria in the sites of study will be included int the study

You may qualify if:

• Age \> 18 years, hospitalized in ICU between 2016-01-01 and 2023-01-01, suffering refractory status epilepticus treated by inhaled Isoflurane as third anticonvulsive therapy

You may not qualify if:

• post-anoxic refractory status epilepticus after cardiac arrest, withdrawal of consent for medical data use

Sponsors & Collaborators

• Hopital of Melun: lead

Study Sites (4)

Ch Bethune Beuvry

Beuvry, 62660, France

Location

CHU Brest

Brest, 29200, France

Location

GH Sud Ile de France, Hôpital de Melun-Sénart

Melun, 77000, France

Location

CH Toulon - Sainte Musse

Toulon, 83000, France

Location

Related Publications (2)

• Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.

  PMID: 34454654 BACKGROUND

• Stetefeld HR, Schaal A, Scheibe F, Nichtweiss J, Lehmann F, Muller M, Gerner ST, Huttner HB, Luger S, Fuhrer H, Bosel J, Schonenberger S, Dimitriadis K, Neumann B, Fuchs K, Fink GR, Malter MP; IGNITE Study Group, with support from the German Neurocritical Care Society (DGNI). Isoflurane in (Super-) Refractory Status Epilepticus: A Multicenter Evaluation. Neurocrit Care. 2021 Dec;35(3):631-639. doi: 10.1007/s12028-021-01250-z. Epub 2021 Jul 20.

  PMID: 34286464 BACKGROUND

MeSH Terms

Conditions

Status Epilepticus

Interventions

Isoflurane

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals

Study Officials

• SEBASTIEN JOCHMANS, MD

  GHSIF MELUN

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Unit

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 26, 2023
• Study Start: June 30, 2024
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

FR (4)