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

Study Description

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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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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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.

Eligibility Criteria

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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).

Contacts and Locations

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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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Drover DR, Schmiesing C, Buchin AF, Ortega HR, Tanner JW, Atkins JH, Macario A. Titration of sevoflurane in elderly patients: blinded, randomized clinical trial, in non-cardiac surgery after beta-adrenergic blockade. J Clin Monit Comput. 2011 Jun;25(3):175-81. doi: 10.1007/s10877-011-9293-1. Epub 2011 Aug 10.

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
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