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
Condition: Anesthesia, General
Intervention: Sedline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

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 in Quality of Life using the QoR-40 (a validated 40-item questionnaire on
      quality of recovery from anesthesia) between the two treatment groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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).