NCT00938782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 19, 2015

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

5.9 years

First QC Date

July 10, 2009

Results QC Date

January 23, 2015

Last Update Submit

February 9, 2015

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Active Monitoring with SEDLine Monitor

ACTIVE COMPARATOR

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

Device: Sedline

Blinded monitoring with SeEDLine Monitor

NO INTERVENTION

Patient group randomized to blinded monitoring with SEDLine monitor for titration of anesthesia. Data captured but not used for titration of anesthesia.

Interventions

SedlineDEVICE
Active Monitoring with SEDLine Monitor

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

  • 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.

    PMID: 21830049DERIVED

Results Point of Contact

Title
Dr. David R Drover
Organization
Stanford University
ddrover@stanford.edu
650-725-0364

Study Officials

  • David R. Drover

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

July 1, 2006

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 19, 2015

Results First Posted

February 19, 2015

Record last verified: 2015-02

Locations

US(2)