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Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice

Sponsor
Azienda Ospedaliero, Universitaria Pisana (Other)
Overall Status
Unknown status
CT.gov ID
NCT01331096
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
200
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Patients in Pisa will undergo thyroid gland surgery. In the protocol group anesthesia will be performed using an automated anesthesia delivery system; preoperative and intra-operative assessment of patients will be performed via video-conferencing from Montreal, which will also monitor and control anesthesia delivery via distant Internet connection - as supervision of functioning of the automated anesthesia delivery system. In the control group anesthesia will be performed in a standard fashion with manual control of the syringe pumps infusing anesthetics drugs.

The hypothesis is that Tele-anesthesia, considered as preoperative assessment and anesthetic control of an automated anesthesia delivery system is feasible and reliable via standard means of internet communication (distant control via virtual network) and performed as well or even better than manual control of the anesthetic drugs infusion.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Time Perspective:
    Prospective
    Official Title:
    Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice
    Study Start Date :
    Mar 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Anesthetic drugs manually administrated
    Automated anesthesia delivery system

    Outcome Measures

    Primary Outcome Measures

    1. Performance of closed-loop system for propofol administration, controlled remotely, compared with the performance of propofol manually administered to maintain in both case the level of hypnosis close to the BIS target. [2 years]

      Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS). A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be determined clinically by recording the % of sedation time during which the actual BIS is within 10% of the target BIS (excellent control), within 11 -20% (good control), between 21-30% (fair control) and beyond 30% of target (inadequate control).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Elective patients

    • Patient scheduled for surgery under spinal anesthesia

    • Patients aged 18 to 85 years

    Exclusion Criteria:

    • Unable to provide informed consent

    • Comatose patients

    • Patients with dementia

    • Allergy to Propofol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliero-Universitaria Pisana Pisa PI Italy 56124

    Sponsors and Collaborators

    • Azienda Ospedaliero, Universitaria Pisana
    • McGill University Health Centre/Research Institute of the McGill University Health Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01331096
    Other Study ID Numbers:
    • Teleanesthesia3054
    First Posted:
    Apr 7, 2011
    Last Update Posted:
    Apr 7, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    thyroid gland resection surgery
    total intravenous anesthesia
    Additional relevant MeSH terms:
    Thyroid Diseases

    Study Results

    No Results Posted as of Apr 7, 2011