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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02013869
Other study ID # 201301
Secondary ID JJ201301
Status Terminated
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date August 2017

Study information

Verified date March 2024
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: ASA 1-2 patient 18 - 65 years scheduled for elective surgery Exclusion Criteria: ASA > 2 heart failure COPD

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas
Desflurane Dialed setting 18 % on the machine gas vaporized
Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated
Desflurane dialed 18% on the machine gas vaporized

Locations

Country Name City State
Sweden Danderyds Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Jan Jakobsson University of California, Irvine

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Adequate anaesthesia Patients will be asked after end of anaesthesia if they have had any recall of intraoperative events 5 hours
Primary 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 amount of inhaled agent consumed ml/min 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. 5 hours
Secondary Postoperative Quality of Recovery Quality of recovery will be followed during the first 72 hours after anaesthesia 72 hours
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