Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice
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|ClinicalTrials.gov Identifier: NCT01331096|
Recruitment Status : Unknown
Verified March 2011 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was: Recruiting
First Posted : April 7, 2011
Last Update Posted : April 7, 2011
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|
|Thyroid Gland Resection|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice|
|Study Start Date :||March 2011|
|Anesthetic drugs manually administrated|
|Automated anesthesia delivery system|
- 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).
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
|Contact: Cedrick Zaouter, MDfirstname.lastname@example.org|
|Azienda Ospedaliero-Universitaria Pisana||Recruiting|
|Pisa, PI, Italy, 56124|
|Contact: Cedrick Zaouter, MD +393284858529 email@example.com|