The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia

Local Anesthesia Clinical Trial

Official title:

The Effect of Dexmedetomidine Subsidiary Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia：A Randomized, Double Blind Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02535273
• Other study ID #: Tangdu-dex-loc
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 20, 2015
• Last updated: August 25, 2015
• Start date: September 2015
• Est. completion date: September 2016

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Local Anesthesia
• Spinal Diseases

Intervention

Drug:
• Dexmedetomidine
load dosage:Intravenous injection dexmedetomidine 1 µg/kg,completed within 10 minutes.
• Lidocaine
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
• Low-dose Dexmedetomidine
maintenance dose:Intravenous infusion of dexmedetomidine 0.3 µg/kg/min until the end of surgery
• Moderate-dose Dexmedetomidine
maintenance dose:Intravenous infusion of dexmedetomidine 0.5 µg/kg/min until the end of surgery
• High-dose Dexmedetomidine
maintenance dose:Intravenous infusion of dexmedetomidine 0.7 µg/kg/min until the end of surgery
• normal saline
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

References & Publications (5)

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

Outcome

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