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):

Intervention(s):

  • Device: Sedline

Phase:

Phase 4

Eligibility


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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Drover
6507250364
Not Recruiting