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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|