Clinical trial NCT02535273: The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia
Official title: The Effect of Dexmedetomidine Subsidiary Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia：A Randomized, Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Diseases
Local Anesthesia
Keywords: dexmedetomidine
prone position
spine surgery
Minimally invasive
local anesthesia
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 Ⅱ grade, or controlled with drugs within Ⅱ 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 ;

Primary outcomes:
measure: Ramsay sedation score
timeFrame: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
measure: visual analogue scale
timeFrame: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
Secondary outcomes:
measure: The total amount of lidocaine
timeFrame: 2h after surgery；
measure: The patient and the surgeon satisfaction
timeFrame: 2h after surgery；
Other outcomes:
Locations:
Study officials:
affiliation: Air Force Military Medical University, China
name: Sun Li
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Gandhi SD, Anderson DG. Minimally invasive surgery for the lumbar spine. J Neurosurg Sci. 2012 Mar;56(1):27-34.
citation: 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.