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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

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ClinicalTrials.gov Identifier: NCT00938782
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
David R. Drover, Stanford University

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.


Condition or disease Intervention/treatment Phase
Anesthesia, General Device: Sedline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Sevoflurane
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Time to Extubation [ Time Frame: Measured from time of end anesthesia to time of tracheal extubation. ]
    The exact time from end of last anesthetic drug to time of tracheal extubation.



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938782


Locations
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, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: David R. Drover Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David R. Drover, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00938782     History of Changes
Other Study ID Numbers: SU-11062007-818
First Posted: July 14, 2009    Key Record Dates
Results First Posted: February 19, 2015
Last Update Posted: February 19, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Sevoflurane
Adrenergic Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action