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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02427971
Other study ID # 2014-A01476-41
Secondary ID
Status Recruiting
Phase N/A
First received April 15, 2015
Last updated April 27, 2015
Start date January 2015
Est. completion date April 2015

Study information

Verified date April 2015
Source Saint Antoine University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

The Aysis® Cs2 ventilator offers an automated control of end-tidal inhalation anesthetic concentration, the EtControl® mode. A low Fresh Gas Flow (FGF) (0.5L/min) is kept during the maintenance of the anesthesia, decreasing the expensive consumption of halogenated agents.

The Perseus® A 500 offers a VaporView® mode that gives the evolution of inspired (Fi) and end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered fraction (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it possible to maintain a low FGF (0.5 L/min), provided the halogen Fd is set to maintain a steady Fe curve.

The goal of this work was to compare the maniability of the intraoperative administered concentrations and the consumption of Desflurane between these 2 modalities of administration.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- patients undergoing a general anesthesia for intra abdominal surgery during more than one hour

- ASA 1or 2

Exclusion Criteria:

- contraindication to halogenated agent

- thoracic surgery

- no french speaking

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Saint-Antoine Paris

Sponsors (1)

Lead Sponsor Collaborator
Saint Antoine University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Consumption of Desflurane between these 2 modalities of administration. Des consumption was measured by micrometric weighing of the vaporizer before and after general anesthesia and a milliliter per min consumption was calculated Time of general anesthesia (1h minimum up to 12h) No
Secondary Comparison of inspired (Fi) and end-tidal (Fe) fractions of halogenated evolution Time of general anesthesia (1h minimum up to 12h) No
Secondary Anesthesia depth monitoring by BIS Time of general anesthesia (1h up to 12h) No
Secondary Hemodynamic stability Number of cardiovascular event which required an intervention
Vasopressive drug
Antihypertensive drug
modification of the Desflurane end-tidal (Fe) fraction
Time of general anesthesia (1h minimum up to 12h) Yes
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