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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anesthesia, General

Intervention / Treatment
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* Device: Sedline


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Monitoring with SEDLine Monitor<br>Patient group randomized to active monitoring with SEDLine monitor for titration of anesthesia. | Device: Sedline<br> <br> |
| No Intervention: Blinded monitoring with SeEDLine Monitor<br>Patient group randomized to blinded monitoring with SEDLine monitor for titration of anesthesia. Data captured but not used for titration of anesthesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Extubation | The exact time from end of last anesthetic drug to time of tracheal extubation. | Measured from time of end anesthesia to time of tracheal extubation. |