Low Flow Anaesthesia, is There a Difference Between 2 Modern Anaesthetic Machines Using Different Gas Reservoir

NCT02013869 | Terminated

• 2 other identifiers: 201301JJ201301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

General Anaesthesia

Keywords

fresh gas flow; quality of anaesthesia; minimal alveolar concentration

Outcome Measures

Primary Outcomes (1)

• Time to reach 1.5 MAC (minimal alveolar concentration) Et

  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

  1 hour

Secondary Outcomes (2)

• amount of inhaled agent consumed ml/min

  5 hours

• Postoperative Quality of Recovery

  72 hours

Other Outcomes (1)

• Adequate anaesthesia

  5 hours

Study Arms (2)

Flow-I

EXPERIMENTAL

Wash in of desflurane (SupraneR) in an anaesthesia machine without below, a new technique that do not have abag/reservoir that is compressed but pushes the gas into the patient. This technique uses far less of fresh gas volume. Thus lower anaesthetic gas will be consumed per hour. The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used.

Device: Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas

Asys

ACTIVE COMPARATOR

Wash in of desflurane (Suprane) in conventional anaesthesia machine Asys, with the anaesthesia machine Asys that has a bag/reservoir that is compressed for insufflation of gas into the patient, thus it is expected that more gas will be consumed per hour. The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used.

Device: Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated

Interventions

Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas DEVICE

Desflurane Dialed setting 18 % on the machine gas vaporized

Flow-I

Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated DEVICE

Desflurane dialed 18% on the machine gas vaporized

Asys

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ASA \> 2 heart failure COPD

Sponsors & Collaborators

• Jan Jakobsson: lead
• University of California, Irvine: collaborator

Study Sites (1)

Danderyds Hospital

Stockholm, Sweden

Location

Study Officials

• Jan g Jakobsson, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adj Professor

Model Details: 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

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 17, 2013
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

SE (1)