A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system

Phase 1

• Conditions: Adult subjects admitted to the ICU clinically indicated to require sedation with propofol and invasive ventilation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-004551-67-DE
• Lead Sponsor: Sedana Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-16
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or female subjects, >= 18 years
2.Continuous invasive ventilation and sedation <= 48 hours at start of study sedation
3.Clinically likely to need invasive ventilation and sedation >= 24 hours at randomisation
4.Ongoing sedation with propofol at time of randomisation
5.Prescribed target sedation depth within the RASS range -1 to -4
6.Signed informed consent or emergency situation inclusion criteria fulfilled and documented, according to procedure described in section 9.4

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 465
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

1.Has not reached prescribed target sedation depth any time within the last 8 hours at randomisation
2.History of or genetic predisposal for malignant hyperthermia
3.Uncompensated acute circulatory failure at time of randomisation (MAP < 55 mmHg despite iv fluids and vasopressors).
4.Hepatic impairment of classification C according to the Child-Pugh score (Cholongitas et al., 2005).
5.Any for the study relevant clinically significant abnormalities in clinical chemistry or haematology results at the time of screening , precluding study participation as judged by the investigator
6.Acute neuropathology without ICP monitoring, including but not limited to stroke, neurosurgery and head trauma.
7.Planned anaesthesia or surgery within 24 hours from randomisation
8.Tidal volume < 350 ml
9.History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
10.Need for continuous muscle relaxation at the time of randomisation
11.Positive pregnancy test in women
12.History of allergy/hypersensitivity to isoflurane or propofol
13.Known participation in any other clinical study that included drug treatment within three months of the first administration of investigational product
14.Documented limitation of medical treatment.

Study & Design

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