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
This study has been completed.
Sponsor:
Stanford University
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
David R. Drover, Stanford University
ClinicalTrials.gov Identifier:
NCT00938782
First received: July 10, 2009
Last updated: November 3, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Anesthesia, General |
Device: Sedline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938782
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, Inc.
Investigators
| Principal Investigator: | David R. Drover | Stanford University |
More Information
No publications provided
| Responsible Party: | David R. Drover, Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00938782 History of Changes |
| Other Study ID Numbers: | SU-11062007-818 |
| Study First Received: | July 10, 2009 |
| Last Updated: | November 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adrenergic Agents Sevoflurane Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013