Anesthesia, General
Conditions
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.
Interventions
DEVICESedline
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Extubation | Measured from time of end anesthesia to time of tracheal extubation. | The exact time from end of last anesthetic drug to time of tracheal extubation. |
Countries
United States
Participant flow
Recruitment details
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups.
Participants by arm
| Arm | Count |
|---|---|
| 1 - SEDLine™ Group Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group). | 32 |
| 2 - CONTROL Group Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group) | 35 |
| Total | 67 |
Baseline characteristics
| Characteristic | 2 - CONTROL Group | 1 - SEDLine™ Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 32 Participants | 67 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74.5 years STANDARD_DEVIATION 6.7 | 75 years STANDARD_DEVIATION 5.7 | 74.8 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 35 participants | 32 participants | 67 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 24 Participants | 20 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 35 |
| serious Total, serious adverse events | 0 / 32 | 0 / 35 |
Outcome results
Primary
Time to Extubation
The exact time from end of last anesthetic drug to time of tracheal extubation.
Time frame: Measured from time of end anesthesia to time of tracheal extubation.
Population: All patients enrolled in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Sedline Group | Time to Extubation | 13.0 minutes | Standard Deviation 5.9 |
| 2 - Control Group | Time to Extubation | 12.5 minutes | Standard Deviation 7.4 |