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

Phase 4

Completed

• Conditions: Anesthesia, General
• Interventions: Device: Sedline

• Registration Number: NCT00938782
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2015-01-23
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-09
• Last Update Submitted: 2015-02-09
• Results First Posted: 2015-02-19
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Monitoring with SEDLine Monitor	Sedline	Patient group randomized to active monitoring with SEDLine monitor for titration of anesthesia.

Primary Outcome Measures

Name	Time	Method
Time to Extubation	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.

Trial Locations

Locations (2)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States