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
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|ClinicalTrials.gov Identifier: NCT00938782|
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia, General||Device: Sedline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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.
- Time to Extubation [ Time Frame: Measured from time of end anesthesia to time of tracheal extubation. ]The exact time from end of last anesthetic drug to time of tracheal extubation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|