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: November 3, 2012
Last verified: November 2012
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:
- Time to extubation [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
|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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||David R. Drover, Associate Professor, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 10, 2009
||November 3, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Platelet Aggregation Inhibitors
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents