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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331096
First Posted: April 7, 2011
Last Update Posted: April 7, 2011
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.
Collaborator:
McGill University Health Center
Information provided by:
Azienda Ospedaliero, Universitaria Pisana
  Purpose

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
Thyroid Gland Resection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • 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. [ Time Frame: 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).


Estimated Enrollment: 200
Study Start Date: March 2011
Groups/Cohorts
Anesthetic drugs manually administrated
Automated anesthesia delivery system

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective thyroid gland surgery
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01331096


Contacts
Contact: Cedrick Zaouter, MD 00393294858529 cedrickzaouter@gmail.com

Locations
Italy
Azienda Ospedaliero-Universitaria Pisana Recruiting
Pisa, PI, Italy, 56124
Contact: Cedrick Zaouter, MD    +393284858529    cedrickzaouter@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
McGill University Health Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01331096     History of Changes
Other Study ID Numbers: Teleanesthesia3054
First Submitted: April 6, 2011
First Posted: April 7, 2011
Last Update Posted: April 7, 2011
Last Verified: March 2011

Keywords provided by Azienda Ospedaliero, Universitaria Pisana:
thyroid gland resection surgery
total intravenous anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs