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

• 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: Stanford University
• Collaborator: Hospira, now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): David R. Drover, Stanford University

Study Description

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

• 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

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

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

• Ages Eligible for Study: 65 Years and older (Older Adult)
• 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

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

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
• 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