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
  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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • 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
Study Population

Patients undergoing elective thyroid gland surgery

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331096

Contacts
Contact: Cedrick Zaouter, MD 00393294858529 cedrickzaouter@gmail.com

Locations
Italy
Azienda Ospedaliero-Universitaria Pisana Recruiting
Pisa, PI, Italy, 56124
Contact: Cedrick Zaouter, MD    +393284858529    cedrickzaouter@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
McGill University Health Center
  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:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014