Status:
COMPLETED
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
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Anesthesia, General
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00938782
Start Date
July 1 2006
End Date
June 1 2012
Last Update
February 19 2015
Active Locations (2)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States