REmimazolam infusion in the context of Hypnotic Shortage in the Critical care Unit during the pandemic of COVID-19. The non-randomized, non-controlled, pilot, open, mono-centric REHSCU study.

Phase 1

• Conditions: general anaesthesia in ICU; MedDRA version: 21.1Level: PTClassification code 10021723Term: Induction and maintenance of anaesthesiaSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-003689-37-FR
• Lead Sponsor: CHU de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-01
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

PRE-INCLUSION CRITERIA
- Next-of-kin, Legal representative written informed consent
- affiliation with French social security system or beneficiary from such system

INCLUSION CRITERIA
- Patients at least 18 years old
- Inclusion in the first 96 hours after ICU admission, after clinical stabilization according to the attending physician’s discretion.
- Expected duration of general anaesthesia = 24 hours

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

-Patients more than 85 years-old
-Refusal to participate
-Severe patients with moribund state within the 24 hours after admission to the ICU
-Withdrawal of Life Sustaining Therapies within the 24 hours after admission to the ICU
-Any pregnant or breast-feeding patient,
-Patients with known anaphylactic reactions to benzodiazepines, flumazenil, or a medical condition such that these agents are contraindicated (according to local label)
-Patients with allergy/hypersensitivity to bovine lactose, dextran or any other excipient in the remimazolam product
-Presence of acute alcoholic or illicit drug intoxication or benzodiazepine intoxication
-Inclusion in another clinical (drug) trial
-Patient under guardianship or trusteeship
-Patient under judicial protection
-Severe hepatic impairment defined as a Child-Pugh score > 10.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified