Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor

Completed · Not applicable

Conditions studied: Acute Cholecystitis, Chronic Cholecystitis

In brief

The purpose of this study is to compare a closed-loop intravenous anesthetic using Bispectral Index as a feedback loop and a controller based on reinforcement learning to titrate dose and intravenous anesthetic that is manually controlled or a standard volatile anesthetic agent titrated by the anesthesiologist to determine improvement in the following parameters as compared to controls: time to discharge from the Post Anesthesia Care Unit, post-operative nausea and vomiting, pain scores and sedation scores.

Key facts

Study ID

NCT01942356

Run by

The University of Texas Health Science Center at San Antonio

People needed

4

Starts

2013-09-01

Expected to finish

2014-08-01

Last updated by the study team

2015-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-65 years of age
• Body mass index lower or equal to 40 m2/kg
• Subjects must be able to comprehend spoken and written English or Spanish

You may not qualify if…

• Any type of psychiatric, neurological, or neuromuscular disorder
• Thyroid disease
• Alcohol consumption which exceeds 2 drinks per day and/or drug abuse.
• Allergy to study medication proposal, soy or egg proteins
• history of drug abuse
• chronic or acute use of opioids, or other medications affecting the central nervous system
• pregnancy

Where it is running

• University Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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