Thyroid Gland Resection Clinical Trial
Official title:
Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice
| NCT number | NCT01331096 |
| Other study ID # | Teleanesthesia3054 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | April 6, 2011 |
| Last updated | April 6, 2011 |
| Start date | March 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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | PI |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Ospedaliero, Universitaria Pisana | McGill University Health Center |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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). | 2 years | No |