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Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble but more expensive anesthetic sevoflurane. Even a small reduction in the duration of hospitalization would easily compensate for the modest additional cost of sevoflurane. The investigators therefore propose to test the primary hypothesis that duration of hospitalization is longer with isoflurane than sevoflurane.
The investigators will also test the secondary hypotheses that: 1) pain scores are greater in patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be adjusted for age, gender, race, baseline risk, 9 and procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoflurane | Experimental | Isoflurane is to be administered to patients in this arm during surgery |
|
| Sevoflurane | Experimental | Sevoflurane is to be administered to patients in this arm during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoflurane | Drug | Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Average Verbal Rating Pain Score | Time-weighted average VRS (Verbal Rating Scale) pain score over the first 72 h after surgery as recorded by nurses at approximately 4-h intervals. The VRS pain score is from 0 (no pain) to 10 (worst imaginable pain). | up to 72 hours after surgery |
| Total Intraoperative Opioid Consumption |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Isoflurane | Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist |
| FG001 | Sevoflurane | Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Isoflurane | Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist |
| BG001 | Sevoflurane |
| 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 | Hospital Length of Stay | Posted | Median | Inter-Quartile Range | Days | participants will be followed for the duration of hospital stay, an expected average of 3 days |
|
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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 | Isoflurane | Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler | Cleveland Clinic Foundation | 216-444-4900 | DS@OR.org |
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| ID | Term |
|---|---|
| D007530 | Isoflurane |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Sevoflurane | Drug | Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist |
|
Total amount of opioid in IV morphine equivalents used during surgeyr |
| intraoperative |
Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Time-weighted Average Verbal Rating Pain Score | Time-weighted average VRS (Verbal Rating Scale) pain score over the first 72 h after surgery as recorded by nurses at approximately 4-h intervals. The VRS pain score is from 0 (no pain) to 10 (worst imaginable pain). | Postoperative pain measurements were not available for 19 isoflurane patients and 20 sevoflurane patients. | Posted | Mean | Standard Deviation | units on a scale | up to 72 hours after surgery |
|
|
|
|
| Secondary | Total Intraoperative Opioid Consumption | Total amount of opioid in IV morphine equivalents used during surgeyr | Posted | Mean | Standard Deviation | mg | intraoperative |
|
|
|
|
| 0 |
| 701 |
| 0 |
| 701 |
| EG001 | Sevoflurane | Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist | 0 | 870 | 0 | 870 |
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| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |