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Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Procedural analgesia and sedation (PAS) with propofol and remifentanil may provides optimal hypnotic and analgesic effects.
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Many anesthetic methods have been used in percutaneous vertebroplasty; however, there is no gold-standard method. Procedural analgesia and sedation (PAS) are one of the commonly used approaches. For its unique properties, including rapid onset, precise intraoperative control, and a fast recovery profile, remifentanil is preferable to other opioids administration in a target-controlled infusion (TCI) pump. Combination of remifentanil with propofol may improve sedation experience; however, it can increase a risk of respiratory depression. Moreover, propofol and remifentanil are often administered with 2 TCI pumps to, respectively, provide hypnotic and analgesic effects, which together are considered to be an ideal anesthetic technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group remifentanil of 1.0 ng/mL | Experimental | Initial remifentanil effect-site concentration of 1.0 ng/mL |
|
| Group remifentanil 2.0 ng/mL | Active Comparator | Initial remifentanil effect-site concentration of 2.0 ng/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial remifentanil effect-site concentration | Drug | Different initial remifentanil effect-site concentration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adequate analgesia at the time of the trocar needle insertion | Remaining moveless at the time of the trocar needle insertion | Time at the trocar needle placement |
| Adequate analgesia at the time of the bone cement injection | Remaining moveless at the time of the bone cement injection | Time at the bone cement injection |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension at the time of the trocar needle placement | Mean blood pressure > 30% decrease from baseline | Time at the trocar needle placement |
| Hypotension at the time of the bone cement injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36086764 | Result | Lai HC, Chen CL, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during transrectal ultrasound-guided prostate biopsy under procedural analgesia and sedation: A randomized controlled study. Medicine (Baltimore). 2022 Sep 9;101(36):e30466. doi: 10.1097/MD.0000000000030466. | |
| 34397727 |
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There is not a plan to make IPD available.
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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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Mean blood pressure > 30% decrease from baseline
| Time at the bone cement injection |
| Apnea with desaturation at the time of the trocar needle placement | Oxygen saturation < 95% | Time at the trocar needle placement |
| Apnea with desaturation at the time of the bone cement injection | Oxygen saturation < 95% | Time at the bone cement injection |
| TCI pump adjustments at the time of the trocar needle placement | Frequency of TCI pump adjustments | Time at the trocar needle placement |
| TCI pump adjustments at the time of the bone cement injection | Frequency of TCI pump adjustments | Time at the bone cement injection |
| Numeric rating scale | Postoperative numeric rating scale. NRS scores is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. | Postoperative one hour |
| Lai HC, Tsai YT, Huang YH, Wu KL, Huang RC, Lin BF, Chan SM, Wu ZF. Comparison of 2 effect-site concentrations of remifentanil with midazolam during percutaneous transluminal balloon angioplasty under monitored anesthesia care: A randomized controlled study. Medicine (Baltimore). 2021 Jul 30;100(30):e26780. doi: 10.1097/MD.0000000000026780. |
| 23839319 | Result | Cannata F, Spinoglio A, Di Marco P, Luzi M, Canneti A, Ricciuti G, Reale C. Total intravenous anesthesia using remifentanil in extracorporeal shock wave lithotripsy (ESWL). Comparison of two dosages: a randomized clinical trial. Minerva Anestesiol. 2014 Jan;80(1):58-65. Epub 2013 Jul 9. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |