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| Name | Class |
|---|---|
| Anecare | INDUSTRY |
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The proposed study will measure the time from the end of surgery until the time patients meet the discharge criteria from the postoperative anesthesia care unit and the time from the end of surgery until the patients regained cognitive function after anesthesia.
Hypercapnia has been used in conjunction with hyperpnoea to provide a more rapid return of responsiveness after inhaled anesthesia. In our first clinical study with isoflurane we confirmed that the time from turning off the vaporizer to opening of eyes was shortened by an average of 62% when the minute ventilation was elevated and the end tidal carbon dioxide concentration was kept at 52 mmHg rather than 28 mmHg during emergence. In our second study we found that hypercapnia and hyperpnoea accelerated recovery proportionately for sevoflurane and desflurane. The benefits of accelerating subject recovery in the operating room may extend to the entire recovery period if the subject is more alert and easier to care for when they arrive in the post anesthesia care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Recovery | Experimental | Quick Emergence Device is in place for phase 1 anesthesia recovery |
|
| Standard of care | Other | Tidal volume and respiratory rate are not changed during phase 1 recovery from anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care for phase one anesthesia care | Other | Patients received intravenous fentanyl at the discretion of the attending anesthesiologist. Anesthesia was induced with a remifentanil infusion, lidocaine, propofol, and rocuronium or succinylcholine at the anesthesiologist's discretion. Maintenance anesthesia was 6% end tidal desflurane with oxygen flows of 2 L/min (though clinicians could deviate from this at their discretion). Clinicians were directed to maintain blood pressure at ±20% of baseline. A baseline remifentanil infusion was used throughout each case, and both remifentanil and fentanyl were titrated at the anesthesiologist's discretion. Ventilation was adjusted to maintain an end tidal carbon dioxide concentration (EtCO2) of 35 mmHg. Ondansetron 4 mg was given prophylactically before the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery From Anesthesia | average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8). | up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Return of Cognitive Function | average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth | up to 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dwayne Westenskow | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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Subjects were recruited from March 28-August 25, 2008 through the surgery schedule at the Moran Eye Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Quick Emergence Device (QED) | At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg. |
| FG001 | Standard of Care | At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wake up After Anesthesia |
| |||||||||||||
| Return of Cognitive Function |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quick Emergence Device (QED) | At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Recovery From Anesthesia | average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8). | Posted | Mean | Standard Deviation | minutes | up to 2 hours |
|
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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 | Quick Emergence Device (QED) | At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dwayne Westenskow, PhD | University of Utah | 801-581-2478 | Dwayne.Westenskow@hsc.utah.edu |
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| ID | Term |
|---|---|
| D006935 | Hypercapnia |
| D006985 | Hyperventilation |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Quick Emergence Device | Device | The Quick Emergence Device is placed between the endotracheal tube and the anesthesia breathing circuit to enable hypercapnia when ventilation is increased. The end-tidal gas sampling line is connected between the device and the endotracheal tube connector. Minute ventilation is doubled and the EtCO2 is elevated to approximately 48 mmHg from the previous maintenance level of 35 mmHg. |
|
|
| NOT COMPLETED |
|
| Standard of Care |
At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Standard of Care |
At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used. |
|
|
|
| Secondary | Return of Cognitive Function | average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth | number of participants determined by protocol | Posted | Jun 2009 | Mean | Standard Deviation | minutes | up to 30 minutes |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Standard of Care | At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used. | 0 | 11 | 0 | 11 |
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| D012140 | Respiratory Tract Diseases |