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Trial record 63 of 228 for:    EDN1

Low Flow Anaesthesia (LF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02013869
Recruitment Status : Terminated (Two of the sites withdraw, did not have capacity to recruit patients)
First Posted : December 17, 2013
Last Update Posted : December 2, 2017
University of California, Irvine
Information provided by (Responsible Party):
Jan Jakobsson, Karolinska Institutet

Brief Summary:
To study the Flow-I breathing circle during low flow general anaesthesia, whether this non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar concentration) and lower consumption of inhaled agent

Condition or disease Intervention/treatment Phase
General Anaesthesia Device: Flow-I Device: Asys Not Applicable

Detailed Description:
Assessing whether there are clinical differences in anaesthetic performance between standard anaesthesia workstation including a below and the new Flow-I device without a below

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We studied the time to reach a MAC value for two fifferent anaesthetic machines, Flow-i versus Aisys looking at the time to reach 1 MAC desflurane
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Low Flow Anaesthesia; Cost-effectiveness of the Flow-I Anaesthesia Machine, a Comparison to Established Anaesthesia Delivery Unit
Study Start Date : May 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: Flow-I
Wash in of desflurane in an anaesthesia machine without below
Device: Flow-I
Desflurane Dialed setting 18 %

Active Comparator: Asys
Wash in of desflurane in conventional anaesthesia machine Asys
Device: Asys
Desflurane dialed 18%

Primary Outcome Measures :
  1. Time to reach 1.5 MAC (minimal alveolar concentration) Et [ Time Frame: 1 hour ]
    The time needed, seconds, to increase the end tidal desflurane concentration during wash-in from a 1 MAC to a 1.5 MAC with a constant fresh gas flow of 1 L/min and the vaporiser set a 3 MAC ( minimal alveolar concentration) (18%) will be compared between the two study groups

Secondary Outcome Measures :
  1. amount of inhaled agent consumed ml/min [ Time Frame: 5 hours ]
    The vaporiser will be weighed before and after each case and the amount of vapor, desflurane, consumed during the anaesthesia will be calculated Gr/min.

  2. Postoperative Quality of Recovery [ Time Frame: 72 hours ]
    Quality of recovery will be followed during the first 72 hours after anaesthesia

Other Outcome Measures:
  1. Adequate anaesthesia [ Time Frame: 5 hours ]
    Patients will be asked after end of anaesthesia if they have had any recall of intraoperative events

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

ASA 1-2 patient 18 - 65 years scheduled for elective surgery

Exclusion Criteria:

ASA > 2 heart failure COPD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02013869

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Danderyds Hospital
Stockholm, Sweden
Sponsors and Collaborators
Jan Jakobsson
University of California, Irvine
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Principal Investigator: Jan g Jakobsson, MD Karolinska Institutet

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Responsible Party: Jan Jakobsson, Adj Professor, Karolinska Institutet Identifier: NCT02013869     History of Changes
Other Study ID Numbers: 201301
JJ201301 ( Other Grant/Funding Number: M201301 )
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Keywords provided by Jan Jakobsson, Karolinska Institutet:
fresh gas flow
quality of anaesthesia
minimal alveolar concentration
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General