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

NCT ID: NCT00938782

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-06-30

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.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Monitoring with SEDLine Monitor

Patient group randomized to active monitoring with SEDLine monitor for titration of anesthesia.

Group Type: ACTIVE_COMPARATOR

Sedline

Intervention Type: DEVICE

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sedline

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

David R. Drover

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R. Drover

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21830049 (View on PubMed)

Other Identifiers

SU-11062007-818

Identifier Type: -

Identifier Source: org_study_id