AnaConDa Long Term Sedation Study (VALTS)

University Health Network, Toronto

Status: Completed

Conditions: Intubated Requiring Sedation for Greater Than 48 Hours

Treatments: Drug: Isoflurane; Drug: Propofol/midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01983800

UHN 13-5845

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• pregnant
• NebulizedFlolan
• tidal volume <350ml
• patients on one lung ventilation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

intravenous propofol/midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Propofol/midazolam

isoflurane

Active Comparator group

Description:

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

Treatment:

Drug: Isoflurane