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Evaluate safety and efficacy of dexmedetomidine in minimally invasive spine surgery under local anesthesia sedation.Explore the appropriate concentration of dexmedetomidine, whether or not can reduce the amount of local anesthetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose Dexmedetomidine | Experimental | load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery |
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| Moderate-dose Dexmedetomidine | Experimental | load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery |
|
| High-dose Dexmedetomidine | Experimental | load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery |
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| normal saline Control group | Placebo Comparator | Intravenous injection normal saline equal quantity，completed within 10 minutes. Local anesthesia: lidocaine Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ramsay sedation score | Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation. | From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours |
| visual analogue scale | Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation. | From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The total amount of lidocaine | 2h after surgery； | |
| The patient and the surgeon satisfaction | four grades：Very satisfied; General satisfied; Not satisfied; Very dissatisfied | 2h after surgery； |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Li | Air Force Military Medical University, China | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23741555 | Background | Nakamura Y, Yabuki S, Kikuchi S, Konno S. Minimally invasive surgery for osteoid osteoma of the cervical spine using microendoscopic discectomy system. Asian Spine J. 2013 Jun;7(2):143-7. doi: 10.4184/asj.2013.7.2.143. Epub 2013 May 22. | |
| 23793558 | Background | Smith N, Masters J, Jensen C, Khan A, Sprowson A. Systematic review of microendoscopic discectomy for lumbar disc herniation. Eur Spine J. 2013 Nov;22(11):2458-65. doi: 10.1007/s00586-013-2848-8. Epub 2013 Jun 23. |
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| Lidocaine | Drug | local anesthesia：0.67% lidocaine local anesthesia layer by layer to the periosteum at the puncture site，Establish puncture channel, injection 5ml 0.67% lidocaine into the vertebral body through the catheter, and observe 5-10min before operation |
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| Low-dose Dexmedetomidine | Drug | maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery |
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| Moderate-dose Dexmedetomidine | Drug | maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery |
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| High-dose Dexmedetomidine | Drug | maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery |
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| normal saline | Drug | Intravenous injection normal saline equal quantity，completed within 10 minutes. Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery |
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| 23873279 | Background | Yoshimoto M, Takebayashi T, Ida K, Tanimoto K, Yamashita T. Microendoscopic discectomy in athletes. J Orthop Sci. 2013 Nov;18(6):902-8. doi: 10.1007/s00776-013-0442-x. Epub 2013 Jul 20. |
| 22415380 | Background | Gandhi SD, Anderson DG. Minimally invasive surgery for the lumbar spine. J Neurosurg Sci. 2012 Mar;56(1):27-34. |
| 23299723 | Background | Arts MP. Reply to the letter to the editor of R. Q. Knight concerning "does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial" by M. Arts, R. Brand, et al. (2011) Eur Spine J 20(1):51-57. doi:10.1007/s00586-012-2491-9. Eur Spine J. 2013 Apr;22(4):899. doi: 10.1007/s00586-012-2643-y. Epub 2013 Jan 9. No abstract available. |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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