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Clinical Trials/NCT01983800
NCT01983800
Completed
Not Applicable

Use of Volatile Anesthetics for Long-Term Sedation In Critically Ill Patients

University Health Network, Toronto2 sites in 1 country60 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Propofol/midazolam
Conditions
Intubated Requiring Sedation for Greater Than 48 Hours
Sponsor
University Health Network, Toronto
Enrollment
60
Locations
2
Primary Endpoint
atmospheric volatile concentration
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Heavy sedation or sleep is a common problem within the intensive care unit (ICU) using our standard intravenous medications. This commonly leads to confusion, low blood pressure, slow wake up and removal of the artificial breathing tube (extubation), which prolongs ICU stay. Using inhaled volatile anesthetic agents are likely to improve these patient outcomes. This unique project is the first North American study looking at using volatiles for patients who need longer-term ICU sedation. This project has excellent potential at lowering these complications and improving quality of care, which will lower patient ICU stay and healthcare costs.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
November 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • adult ICU patients expected to be ventilated \> 48 hours

Exclusion Criteria

  • age \< 18 years
  • history of malignant hyperthermia
  • propofol infusion syndrome
  • evidence of raised intracranial pressure
  • 6-month mortality risk from pre-existing condition \> 50%
  • lack of commitment to maximal treatment
  • NebulizedFlolan
  • tidal volume \<350ml
  • patients on one lung ventilation

Arms & Interventions

intravenous propofol/midazolam

Sedation using intravenous propofol/midazolam, sedation will be titrated to a Riker Agitation Sedation Score

Intervention: Propofol/midazolam

isoflurane

Sedation using inhaled isoflurane, sedation will be titrated to a Riker Agitation Sedation Score

Intervention: Isoflurane

Outcomes

Primary Outcomes

atmospheric volatile concentration

Time Frame: daily

Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer

Sedation

Time Frame: daily

adherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4

Feasibility

Time Frame: 2 years

assess rate of patient recruitment and barriers to recruitment

Education Tool

Time Frame: 2 years

multidisciplinary feedback regarding teaching package, protocol, quality of sedation

serum fluoride levels

Time Frame: every 2 days

Measurements will be taken 24 hours post sedation and every 2 days until while on sedation followed by 2 further samples after discontinuation of sedation.

Study Sites (2)

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