Local Anesthesia Clinical Trial
Official title:
The Effect of Dexmedetomidine Subsidiary Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesiaļ¼A Randomized, Double Blind Controlled Trial
Verified date | August 2015 |
Source | Tang-Du Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 212 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Sign the informed consent; - American Society of Anesthesiologists (ASA)classification:class I~II;Elective minimally invasive spine surgery; - Age =18 years old, weighing 45 ~ 80 Kg, height 151 ~ 185 cm; - hypertension within ? grade, or controlled with drugs within ? level; - Diabetes fasting in 8.3mol/L or less Exclusion Criteria: - DEX allergy; - Change anesthesia preoperative or intraoperative ; - metabolic disorders, anemia has not been corrected; - recent patients receiving sedatives and antidepressants; - degenerative diseases of the central nervous elderly persons; - serious central nervous system diseases (acute stroke, uncontrolled epilepsy, severe dementia); - hypovolemia; 8) unstable angina or acute myocardial infarction; - left ventricular ejection fraction less than 30%, heart rate lower than 45bpm; - II-III degree heart block; - acute hepatitis or severe liver disease (liver function C level); - patients with renal insufficiency randomly assigned to receive treatment, but If patients need dialysis test is excluded or interruption ; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Tang-Du Hospital |
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. — View Citation
Gandhi SD, Anderson DG. Minimally invasive surgery for the lumbar spine. J Neurosurg Sci. 2012 Mar;56(1):27-34. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | 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 | Yes |
Secondary | The total amount of lidocaine | 2h after surgery; | Yes | |
Secondary | The patient and the surgeon satisfaction | four grades:Very satisfied; General satisfied; Not satisfied; Very dissatisfied | 2h after surgery; | Yes |
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