NCT01069562 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Agarwal J, Puri GD, Mathew PJ
Comparison of closed loop vs. manual administration of propofol using the Bispectral index in cardiac surgery. Acta Anaesthesiol Scand. 2009 Mar;53(3):390-7. doi: 10.1111/j.1399-6576.2008.01884.x.
Locher S, Stadler KS, Boehlen T, Bouillon T, Leibundgut D, Schumacher PM, Wymann R, Zbinden AM
A new closed-loop control system for isoflurane using bispectral index outperforms manual control. Anesthesiology. 2004 Sep;101(3):591-602.
Puri GD, Kumar B, Aveek J
Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007 Jun;35(3):357-62.
Varvel JR, Donoho DL, Shafer SL
Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94.

Comparison of Isoflurane Anaesthesia by Closed Loop Controlled Administration Versus Manually Controlled Administration Using Bispectral Index in Open Heart Surgery

Details for clinical trial NCT01069562

Clinical trial NCT01069562 - References