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

This study has been completed.

Sponsor:

Collaborator:

Hospira, Inc.

Information provided by (Responsible Party):

David R. Drover, Stanford University

ClinicalTrials.gov Identifier:

NCT00938782

First received: July 10, 2009

Last updated: February 9, 2015

Last verified: February 2015

History of Changes

Purpose

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	Intervention	Phase
Anesthesia, General	Device: Sedline	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Time to Extubation [ Time Frame: Measured from time of end anesthesia to time of tracheal extubation. ] [ Designated as safety issue: No ]
The exact time from end of last anesthetic drug to time of tracheal extubation.


Enrollment:	67
Study Start Date:	July 2006
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Stanford University

Hospira, Inc.

Investigators


Principal Investigator:	David R. Drover	Stanford University

More Information

No publications provided


Responsible Party:	David R. Drover, Associate Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT00938782 History of Changes
Other Study ID Numbers:	SU-11062007-818
Study First Received:	July 10, 2009
Results First Received:	January 23, 2015
Last Updated:	February 9, 2015
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 01, 2015

To Top