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
Determine ED50 dexmedetomidine adjuvant that can provide spinal anesthetic sensory blockade duration of 200 minutes on knee and pelvis surgery with up-and-down method.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 3 mcg | Experimental | Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg. |
|
| Dexmedetomidine 4 mcg | Experimental | Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg. |
|
| Dexmedetomidine 5 mcg | Experimental | Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg. |
|
| Dexmedetomidine 6 mcg | Experimental | Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine 3 mcg | Drug | Patient received spinal injection of dexmedetomidine 3 mcg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Effective Sensory Blockade (≥200 Minutes) | Effectiveness is defined as a sensory blockade duration of at least 200 minutes from administration of spinal anesthesia with adjuvant dexmedetomidine to regression of sensory level to the T12 dermatome. Participants with blockade duration <200 minutes will be considered not effective. | Until the end of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension Incidence | Whether the patient experienced drop in blood pressure (systolic, diastolic, and mean arterial pressure) > 20% from base value. | At the start of surgery until the end of surgery |
| Bradycardia Incidence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN Cipto Mangunkusumo | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexmedetomidine 4 mcg | Drug | Patient received spinal injection of dexmedetomidine 4 mcg. |
|
| Dexmedetomidine 5 mcg | Drug | Patient received spinal injection of dexmedetomidine 5 mcg. |
|
| Dexmedetomidine 6 mcg | Drug | Patient received spinal injection of dexmedetomidine 6 mcg. |
|
| Bupivacain hyperbaric 0.5% 12.5 mg | Drug | Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg |
|
Whether patient experienced drop in heart rate to <50 beat per minute.
| Until the end of surgery |
| Nausea Incidence | Whether patient experienced persistent nausea that cause vomiting. | Until the end of surgery |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided