Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice
Recruitment status was Recruiting
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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 |
- 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).
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2011 |
| Groups/Cohorts |
|---|
| Anesthetic drugs manually administrated |
| Automated anesthesia delivery system |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing elective thyroid gland surgery
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| Contact: Cedrick Zaouter, MD | 00393294858529 | cedrickzaouter@gmail.com |
| Italy | |
| Azienda Ospedaliero-Universitaria Pisana | Recruiting |
| Pisa, PI, Italy, 56124 | |
| Contact: Cedrick Zaouter, MD +393284858529 cedrickzaouter@gmail.com | |
More Information
No publications provided by Azienda Ospedaliero, Universitaria Pisana
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01331096 History of Changes |
| Other Study ID Numbers: | Teleanesthesia3054 |
| Study First Received: | April 6, 2011 |
| Last Updated: | April 6, 2011 |
| Health Authority: | Italy: Agenzia Italiana del Farmaco |
Keywords provided by Azienda Ospedaliero, Universitaria Pisana:
|
thyroid gland resection surgery total intravenous anesthesia |
Additional relevant MeSH terms:
|
Thyroid Diseases Endocrine System Diseases Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013