Duration of Hospitalization
Conditions
Keywords
Sevoflurane, Isoflurane, volatile anesthetic, duration of hospitalization
Brief summary
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.
Interventions
DRUGIsoflurane
Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
DRUGSevoflurane
Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Must have surgery in G operating room suite
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital Length of Stay | participants will be followed for the duration of hospital stay, an expected average of 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Average Verbal Rating Pain Score | up to 72 hours after surgery | 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). |
| Total Intraoperative Opioid Consumption | intraoperative | Total amount of opioid in IV morphine equivalents used during surgeyr |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 714 |
| 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 | 870 |
| Total | 1,584 |
Baseline characteristics
| Characteristic | Isoflurane | Sevoflurane | Total |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 16.5 | 53.6 years STANDARD_DEVIATION 16.6 | 53.5 years STANDARD_DEVIATION 16.6 |
| Sex: Female, Male Female | 408 Participants | 502 Participants | 910 Participants |
| Sex: Female, Male Male | 306 Participants | 368 Participants | 674 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 701 | 0 / 870 |
| serious Total, serious adverse events | 0 / 701 | 0 / 870 |
Outcome results
Primary
Hospital Length of Stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Isoflurane | Hospital Length of Stay | 4.9 Days |
| Sevoflurane | Hospital Length of Stay | 4.4 Days |
p-value: 0.2495% CI: [0.97, 1.16]Wilcoxon (Mann-Whitney)
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).
Time frame: up to 72 hours after surgery
Population: Postoperative pain measurements were not available for 19 isoflurane patients and 20 sevoflurane patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isoflurane | Time-weighted Average Verbal Rating Pain Score | 3.6 units on a scale | Standard Deviation 1.9 |
| Sevoflurane | Time-weighted Average Verbal Rating Pain Score | 3.6 units on a scale | Standard Deviation 1.8 |
p-value: 0.8795% CI: [-0.23, 0.19]Generalized estimating equation model
Secondary
Total Intraoperative Opioid Consumption
Total amount of opioid in IV morphine equivalents used during surgeyr
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isoflurane | Total Intraoperative Opioid Consumption | 32 mg | Standard Deviation 1.3 |
| Sevoflurane | Total Intraoperative Opioid Consumption | 33 mg | Standard Deviation 1.6 |
p-value: 0.7495% CI: [-4.7, 3.3]Generalized estimating equation model