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The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
Background: The investigator evaluated the motor and sensory block durations and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon's anesthesia in patients undergoing vitreoretinal surgery. Motor and sensory block durations were considered as a primary endpoint.
Methods: The investigator investigated 60 patients subjected to vitreoretinal surgery under sub-Tenon's anesthesia. The patients were randomly divided equally into 1 of 2 groups conferring to the local anesthesia (LA) solution used to receive either 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline (group L) or 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline (group LD). The total volume of the LA solution used was 5 mL. Motor block (akinesia) and sensory block durations were evaluated until the return of normal motor and sensory function. The sedation level was assessed during the surgery period and 24 hours postoperatively together with the degree of postoperative pain and the efficiency of postoperative analgesia. The sleep quality of the first postoperative night was assessed using the Consensus Sleep Diary (CSD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group L | No Intervention | receive 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU diluted with 1mL normal saline | |
| group LD | Active Comparator | 4 mL of levobupivacaine 0.75% plus hyaluronidase 15 IU and dexmedetomidine 20 μg diluted with 1mL normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | adding dexmedetomidine to the local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| the motor and sensory block durations | expected to be extended in group LD | participants will be followed for the duration of hospital stay, an expected average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| sleep quality of the 1st postoperative night | improved the sleep quality | 24 hours |
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inclusion criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 1, 2016 | |
| Reset | Mar 30, 2016 | |
| Release | Mar 6, 2019 | |
| Reset | Jun 6, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 1, 2016 | Mar 30, 2016 | |||
| Mar 6, 2019 |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Jun 6, 2019 |