Comparison of Extubation Delay After Prolonged Sedation

NCT04710914 | Terminated Phase 4 DMC

• 1 other identifier: 2018/0348/HP
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This monocentric, prospective, controlled, randomized, single-blind study will be conducted in surgical resuscitation at the Rouen University Hospital. The aim of our research project is to evaluate the extubation time after sedation with inhaled isoflurane compared to conventional intravenous sedation with midazolam, in patients who require prolonged sedation (3 to 28 days) in a context of septic shock. This population is particularly at risk of hypnotic accumulation due to the prolonged duration of use and the increased risk of developing renal or hepatic impairment in connection with septic shock. Based on data from the literature on shorter durations of up to 96 hours of sedation, the investigators expect a decrease in the time to extubation in patients sedated with isoflurane as well as a better quality of awakening with a decrease in resuscitation delirium. This shortened duration of mechanical ventilation could have beneficial effects on the morbidity associated with prolonged sedation and ventilation: reduction of pneumopathies acquired under mechanical ventilation, reduction of the length of stay in resuscitation and hospitalization.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• The delay between the first sedation stop and extubation

  The delay between the first sedation stop and extubation. This time will be measured from the first interruption of sedation to the patient's extubation. If the patient needs to be resedated prior to extubation, the stop of sedation for the primary endpoint measurement will be the first stop of sedation.

  10 days

Secondary Outcomes (10)

• Wake-up time

  10 days

• Total duration of sedation and mechanical ventilation

  90 days

• Total duration of intensive care and hospital stay

  90 days

• A measure of overall survival at 90 days defined by the duration between the inclusion date and the date of death.

  90 days

• Measurement of wake-up time defined by the duration between the day of the first sedation stop and a RASS score of 0,

  10 days

Study Arms (2)

sedation by inhaled isoflurane

EXPERIMENTAL

sedation by midazolam with the MIRUS device

Drug: Prolonged sedation with isoflurane

sedation with intravenous midazolam

ACTIVE COMPARATOR

continuation of sedation with intravenous midazolam

Drug: Prolonged sedation with midazolam

Interventions

Prolonged sedation with isoflurane DRUG

Adult patients admitted to the surgical intensive care unit at the Rouen University Hospital for septic shock and requiring sedation for more than 3 days and a maximum of 10 days will be randomised in two groups. The experimental group will receive sedation by inhaled isoflurane The control group will receive sedation by intravenous midazolam

sedation by inhaled isoflurane

Prolonged sedation with midazolam DRUG

Adult patients admitted to the surgical intensive care unit at the Rouen University Hospital for septic shock and requiring sedation for more than 3 days and a maximum of 10 days will be randomised in two groups. The experimental group will receive sedation by inhaled isoflurane The control group will receive sedation by intravenous midazolam

sedation with intravenous midazolam

Eligibility Criteria

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

You may qualify if:

• Major patients,
• Sedated with midazolam and sufentanil for a maximum of 3 days and ventilated invasively,
• Presenting septic shock according to the SEPSIS-3 definition with the following 4 criteria :
• Clinical suspicion of infection or positive microbiological sample if applicable,
• Organ Failure: SOFA (Sepsis-related Organ Failure Assessment) ≥ 2 (Annex n°5),
• Need for vasoactive amines to maintain sufficient organ perfusion pressure,
• Arterial lactate \> 2mmol/l,
• Stabilized septic shock without the need to increase noradrenaline doses over the last 6 hours,
• For women, absence of current pregnancy: negative pregnancy test,
• Subjects affiliated to a social security system.
• If the patient is unable to sign the consent (emergency situation) the consent will be signed by his or her representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned). In this case, the patient will subsequently be asked for consent to continue the study.

You may not qualify if:

• Refusal of the patient to continue the study after waking up,
• Duration of sedation after randomization less than 3 days or more than 10 days.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 760031, France

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Isoflurane; Midazolam

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Antoine LEFEVRE-SCELLES, Doctor

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 15, 2021
• Study Start: December 15, 2020
• Primary Completion: December 26, 2020
• Study Completion: December 26, 2020
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (1)