Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Hospira, now a wholly owned subsidiary of Pfizer

Stanford Investigator(s):


  • Device: Sedline


Phase 4


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

65 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Drover
Not Recruiting