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