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SEDLine Study: A 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
This study is ongoing, but not recruiting participants.
First Received: July 10, 2009   Last Updated: July 13, 2009   History of Changes
Sponsors and Collaborators: Stanford University
Hospira, Inc.
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00938782
  Purpose

Assess 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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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 of extubation

Secondary Outcome Measures:
  • QOR-40

Estimated Enrollment: 56
Study Start Date: July 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938782

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

No publications provided

Responsible Party: Stanford University School of Medicine ( David R. Drover, Principal Investigator )
Study ID Numbers: SU-11062007-818
Study First Received: July 10, 2009
Last Updated: July 13, 2009
ClinicalTrials.gov Identifier: NCT00938782     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Anesthetics, Inhalation
Adrenergic Agents
Anesthetics, General
Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Sevoflurane

Additional relevant MeSH terms:
Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Sevoflurane

ClinicalTrials.gov processed this record on September 11, 2009