Clinical trial NCT00938782: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, General
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2009-07-14
Enrollment: 67
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Time to Extubation
timeFrame: Measured from time of end anesthesia to time of tracheal extubation.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: David R. Drover
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drover DR, Schmiesing C, Buchin AF, Ortega HR, Tanner JW, Atkins JH, Macario A. Titration of sevoflurane in elderly patients: blinded, randomized clinical trial, in non-cardiac surgery after beta-adrenergic blockade. J Clin Monit Comput. 2011 Jun;25(3):175-81. doi: 10.1007/s10877-011-9293-1. Epub 2011 Aug 10.