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

This study has been completed.
Hospira, Inc.
Information provided by (Responsible Party):
David R. Drover, Stanford University Identifier:
First received: July 10, 2009
Last updated: February 9, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Anesthesia, General
Device: Sedline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Time to Extubation [ Time Frame: Measured from time of end anesthesia to time of tracheal extubation. ] [ Designated as safety issue: No ]
    The exact time from end of last anesthetic drug to time of tracheal extubation.

Enrollment: 67
Study Start Date: July 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Monitoring with SEDLine Monitor
Patient group randomized to active monitoring with SEDLine monitor for titration of anesthesia.
Device: Sedline
No Intervention: Blinded monitoring with SeEDLine Monitor
Patient group randomized to blinded monitoring with SEDLine monitor for titration of anesthesia. Data captured but not used for titration of anesthesia.


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its identifier: NCT00938782

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Stanford University
Hospira, Inc.
Principal Investigator: David R. Drover Stanford University
  More Information

No publications provided

Responsible Party: David R. Drover, Associate Professor, Stanford University Identifier: NCT00938782     History of Changes
Other Study ID Numbers: SU-11062007-818
Study First Received: July 10, 2009
Results First Received: January 23, 2015
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses processed this record on November 27, 2015