Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.
Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty.
After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPV6E1 | Experimental |
| |
| BPV7E1 | Experimental |
| |
| BPV8E1 | Experimental |
| |
| BPV9E1 | Experimental |
| |
| BPV10E1 | Experimental |
| |
| BPV11E1 | Experimental |
| |
| BPV6E2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrathecal bupivacaine 6 mg with 100 mcg of epinephrine | Drug | intrathecal bupivacaine 6 mg with 100 mcg of epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| the success of anesthesia | The individual dose would be considered to be successful if no epidural supplement is required during surgery. | during the surgery (average two hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of the various intrathecal bupivacaine dose | lowest systolic blood pressure, vasopressure requirements, nausea, vomitting | during surgery (average two hours) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Won Ho Kim, M.D. | Seoul Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Medical Center | Seoul | 135-740 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BPV7E2 | Experimental |
|
| BPV8E2 | Experimental |
|
| BPV9E2 | Experimental |
|
| BPV10E2 | Experimental |
|
| BPV11E2 | Experimental |
|
| intrathecal bupivacaine 7 mg with 100 mcg of epinephrine | Drug | intrathecal bupivacaine 7 mg with 100 mcg of epinephrine |
|
|
| intrathecal bupivacaine 8 mg with 100 mcg of epinephrine | Drug | intrathecal bupivacaine 8 mg with 100 mcg of epinephrine |
|
|
| intrathecal bupivacaine 9 mg with 100 mcg of epinephrine | Drug | intrathecal bupivacaine 9 mg with 100 mcg of epinephrine |
|
|
| intrathecal bupivacaine 10 mg with 100 mcg of epinephrine | Drug | intrathecal bupivacaine 10 mg with 100 mcg of epinephrine |
|
|
| intrathecal bupivacaine 11 mg with epinephrine 100 mcg | Drug | intrathecal bupivacaine 11 mg with epinephrine 100 mcg |
|
|
| intrathecal bupivacaine 6 mg with 200 mcg of epinephrine | Drug | intrathecal bupivacaine 6 mg with 200 mcg of epinephrine |
|
|
| intrathecal bupivacaine 7 mg with 200 mcg of epinephrine | Drug | intrathecal bupivacaine 7 mg with 200 mcg of epinephrine |
|
|
| intrathecal bupivacaine 8 mg with 200 mcg of epinephrine | Drug | intrathecal bupivacaine 8 mg with 200 mcg of epinephrine |
|
|
| intrathecal bupivacaine 9 mg with 200 mcg of epinephrine | Drug | intrathecal bupivacaine 9 mg with 200 mcg of epinephrine |
|
|
| intrathecal bupivacaine 10 mg with 200 mcg of epinephrine | Drug | intrathecal bupivacaine 10 mg with 200 mcg of epinephrine |
|
|
| intrathecal bupivacaine 11 mg with 200 mcg of epinephrine | Drug | intrathecal bupivacaine 11 mg with 200 mcg of epinephrine |
|
|
| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
Not provided
Not provided