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Comparison of Extubation Delay After Prolonged Sedation

NCT04710914 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-02-10

No results posted yet for this study

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

Interventions

DRUG

Prolonged sedation with isoflurane

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

DRUG

Prolonged sedation with midazolam

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

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Antoine LEFEVRE-SCELLES, Doctor · University Hospital, Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2020-12-26
Completion
2020-12-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710914 on ClinicalTrials.gov