Using the SEDLine for the Titration of Sevoflurane in Elderly Patients Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade
Asses the effect of the use of Patient State Index (PSI) monitoring on difference in emergence profiles in the elderly (age >65 yrs) population to develop a cost-benefit profile.
Assess differences in Quality of Life using the QoR-40 (a validated 40-item questionnaire on quality of recovery from anesthesia) between the two treatment groups.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Double-Blinded Study of the Effect on Improved Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade|
- Time to Extubation [ Time Frame: Measured from time of end anesthesia to time of tracheal extubation. ] [ Designated as safety issue: No ]The exact time from end of last anesthetic drug to time of tracheal extubation.
|Study Start Date:||July 2006|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Active Monitoring with SEDLine Monitor
Patient group randomized to active monitoring with SEDLine monitor for titration of anesthesia.
No Intervention: Blinded monitoring with SeEDLine Monitor
Patient group randomized to blinded monitoring with SEDLine monitor for titration of anesthesia. Data captured but not used for titration of anesthesia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938782
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|Principal Investigator:||David R. Drover||Stanford University|