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

Anesthesia, General Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938782
• Other study ID #: SU-11062007-818
• Status: Completed
• Phase: Phase 4
• First received: July 10, 2009
• Last updated: February 9, 2015
• Start date: July 2006
• Est. completion date: June 2012

Study information

• Verified date: February 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• Sedline

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Extubation	The exact time from end of last anesthetic drug to time of tracheal extubation.	Measured from time of end anesthesia to time of tracheal extubation.	No