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We investigated the efficacy and the safety of the pharmacokinetic model-based patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after total intravenous anesthesia (TIVA).
Infusions of fentanyl (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr, or at the decremental rates of 6.0 ml/hr or 8.0 ml/hr during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FX2-2-2 | Experimental | Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr |
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| D6-4-2 | Active Comparator | Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the decremental rates of 6.0 ml/hr (D6-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, |
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| D8-4-2 | Active Comparator | Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at at the decremental rates of 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FX2-2-2 | Other | Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scores (VAS) | The assessments of analgesia and patient condition were performed at the time points of immediate post-operative periods (1, 15, 30, 45, and 60 min) and post-operative 2, 3, 4, 6, 12 and 24 hr. | until post-operative 24 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Yeop Kim, M.D | Ajou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University School of Medicine | Suwon | Gyeongki-do | 443-721 | South Korea |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| D6-4-2 | Other | Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated. |
|
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| D8-4-2 | Other | Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated. |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |