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

NCT00938782

Last updated date
Study Location
Stanford University School of Medicine
Stanford, California, 94305, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
General Anesthesia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia, General
Intervention  ICMJE Device: Sedline
Study Arms  ICMJE
  • Active Comparator: Active Monitoring with SEDLine Monitor
    Patient group randomized to active monitoring with SEDLine monitor for titration of anesthesia.
    Intervention: 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2015)
67
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2009)
56
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00938782
Other Study ID Numbers  ICMJE SU-11062007-818
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David R. Drover, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:David R. DroverStanford University
PRS Account Stanford University
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP