An interventional study of Isoflurane and Sevoflurane in Duration of Hospitalization, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-04-10.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Health services research
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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Inclusion Criteria:
Isoflurane is to be administered to patients in this arm during surgery
Drug: Isoflurane
Sevoflurane is to be administered to patients in this arm during surgery
Drug: Sevoflurane
Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Hospital Length of Stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
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).
Time frame: up to 72 hours after surgery
Total Intraoperative Opioid Consumption
Total amount of opioid in IV morphine equivalents used during surgeyr
Time frame: intraoperative
| Milestone | Isoflurane | Sevoflurane |
|---|---|---|
| Started | 714 | 870 |
| Completed | 714 | 870 |
| Not completed | 0 | 0 |
| Days | Isoflurane | Sevoflurane |
|---|---|---|
| Hospital Length of Stay | 4.9 (2.0 to 8.4) | 4.4 (1.5 to 7.8) |
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).
| units on a scale | Isoflurane | Sevoflurane |
|---|---|---|
| Time-weighted Average Verbal Rating Pain Score | 3.6 ± 1.9 | 3.6 ± 1.8 |
Total amount of opioid in IV morphine equivalents used during surgeyr
| mg | Isoflurane | Sevoflurane |
|---|---|---|
| Total Intraoperative Opioid Consumption | 32 ± 1.3 | 33 ± 1.6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Isoflurane | — | 0/701 (0%) | 0/701 (0%) |
| Sevoflurane | — | 0/870 (0%) | 0/870 (0%) |
| Age, Continuous(years) | Isoflurane | Sevoflurane | Total |
|---|---|---|---|
| Mean | 53.4 ± 16.5 | 53.6 ± 16.6 | 53.5 ± 16.6 |
| Sex: Female, Male(Participants) | Isoflurane | Sevoflurane | Total |
|---|---|---|---|
| Female | 408 | 502 | 910 |
| Male | 306 | 368 | 674 |
Plan to share: No
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