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
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- 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.
- 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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Descriptive Information | ||||
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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 |
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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 | 67 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |