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

• Conditions: Thyroid Gland Resection

• Registration Number: NCT01331096
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-03
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-06
• Last Update Submitted: 2011-04-06
• Study First Posted: 2011-04-07
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy