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
This study has been completed.
Information provided by (Responsible Party):
David R. Drover, Stanford University
First received: July 10, 2009
Last updated: February 9, 2015
Last verified: February 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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||65 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patient is male or female.
- Patient is 65 years of age or older.
- Patient has a physical status between ASA I and III. (Appendix C).
- Patient scheduled for general anesthesia for non-cardiac surgery expected to last at least one hour.
- Patient able to communicate in English.
- Patient has signed an approved informed consent.
- Patient's age is less than 65 years
- Anesthetic duration of less than one hour expected
- Treatment of beta blockers contra-indicated
- Not a candidate for general anesthesia
- Patient requires regional anesthesia with general anesthesia.
- ASA physical status of IV or V. (Appendix C)
- Patient has known drug or alcohol abuse.
- Patient has scalp or skull abnormalities such as psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants (such as plates, shunts, etc.).
- Patient has experienced a head injury with loss of consciousness within the last year.
- Patient has known neurological and psychiatric disorder that interferes with the patient's level of consciousness.
- Known concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, SSRIs, neuroleptics, anxiolytics or antipsychotics).
- Patient has any medical condition which, in the judgment of the investigator, renders them inappropriate for participation in this study, such as Guillen Bare syndrome
- Known hypersensitivity to the intended anesthetic agents including significant post-operative nausea or vomiting.
- Uncontrolled hypertension (unresponsive to medication): Systolic BP > 180 mmHg or Diastolic BP > 105 mmHg
- Pre-Op baseline heart rate < 45 beats per minute
- Weight 50% greater than ideal body weight
- Already monitored for EP or EEG, i.e., Spinal cord cases
- Actual anesthetic duration < 1 hour (assessed after emergence).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00938782
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
|University of Pennsylvania
|Philadelphia, Pennsylvania, United States |
||David R. Drover
No publications provided
ClinicalTrials.gov processed this record on March 26, 2015
||David R. Drover, Associate Professor, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 10, 2009
|Results First Received:
||January 23, 2015
||February 9, 2015
||United States: Food and Drug Administration