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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Monitoring with SEDLine Monitor | Active Comparator | Patient group randomized to active monitoring with SEDLine monitor for titration of anesthesia. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedline | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Drover | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21830049 | Derived | 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. |
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Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 2- Control Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Philadelphia |
| Pennsylvania |
| United States |
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. |
| COMPLETED |
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| NOT COMPLETED |
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Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Extubation | The exact time from end of last anesthetic drug to time of tracheal extubation. | All patients enrolled in both groups. | Posted | Mean | Standard Deviation | minutes | Measured from time of end anesthesia to time of tracheal extubation. |
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1 day during anesthesia period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 - SEDLine Group | Patient groups randomized to active monitoring. This group had Sedline monitor used to titrate anesthesia. | 0 | 32 | 0 | 32 | ||
| EG001 | Group 2 - Control Group | Patient groups randomized to monitoring with blinded data not used to titrate anesthesia. | 0 | 35 | 0 | 35 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David R Drover | Stanford University | 650-725-0364 | ddrover@stanford.edu |
| >=65 years |
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| Male |
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