AnaConDa Long Term Sedation Study

NCT ID: NCT01983800

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intubated Requiring Sedation for Greater Than 48 Hours

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravenous propofol/midazolam

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

Group Type ACTIVE_COMPARATOR

Propofol/midazolam

Intervention Type DRUG

isoflurane

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

Group Type ACTIVE_COMPARATOR

Isoflurane

Intervention Type DRUG

Interventions

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Isoflurane

Intervention Type DRUG

Propofol/midazolam

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Jerath, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

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Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Jerath A, Ferguson ND, Steel A, Wijeysundera D, Macdonald J, Wasowicz M. The use of volatile anesthetic agents for long-term critical care sedation (VALTS): study protocol for a pilot randomized controlled trial. Trials. 2015 Dec 9;16:560. doi: 10.1186/s13063-015-1083-5.

Reference Type DERIVED
PMID: 26646404 (View on PubMed)

Other Identifiers

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UHN 13-5845

Identifier Type: -

Identifier Source: org_study_id

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