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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
McGill University Health Center
Information provided by:
Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier:
NCT01331096
First received: April 6, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

April 6, 2011
April 6, 2011
March 2011
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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 ] [ Designated as safety issue: No ]
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).
Same as current
No Changes Posted
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Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice
Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients undergoing elective thyroid gland surgery

Thyroid Gland Resection
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  • Anesthetic drugs manually administrated
  • Automated anesthesia delivery system
Hemmerling TM, Arbeid E, Wehbe M, Cyr S, Giunta F, Zaouter C. Transcontinental anaesthesia: a pilot study. Br J Anaesth. 2013 May;110(5):758-63. doi: 10.1093/bja/aes498. Epub 2013 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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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
Both
18 Years to 85 Years
No
Contact: Cedrick Zaouter, MD 00393294858529 cedrickzaouter@gmail.com
Italy
 
NCT01331096
Teleanesthesia3054
Yes
Not Provided
Azienda Ospedaliero, Universitaria Pisana
McGill University Health Center
Not Provided
Azienda Ospedaliero, Universitaria Pisana
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP