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
Trial ID or NCT#
Status
Purpose
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
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
Eligibility 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.
- - 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).
Investigator(s)
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Contact
David Drover
6507250364
View on ClinicalTrials.gov