The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia
1 other identifier
interventional
212
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2015
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
August 28, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedAugust 28, 2015
August 1, 2015
11 months
August 20, 2015
August 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
The total amount of lidocaine
2h after surgery；
The patient and the surgeon satisfaction
2h after surgery；
Study Arms (4)
Low-dose Dexmedetomidine
EXPERIMENTALload 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
Moderate-dose Dexmedetomidine
EXPERIMENTALload 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
EXPERIMENTALload 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
normal saline Control group
PLACEBO COMPARATORIntravenous 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
Interventions
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
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
maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 ;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tang-Du Hospitallead
Related Publications (5)
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.
PMID: 23741555BACKGROUNDSmith 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.
PMID: 23793558BACKGROUNDYoshimoto 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.
PMID: 23873279BACKGROUNDGandhi SD, Anderson DG. Minimally invasive surgery for the lumbar spine. J Neurosurg Sci. 2012 Mar;56(1):27-34.
PMID: 22415380BACKGROUNDArts 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.
PMID: 23299723BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sun Li
Air Force Military Medical University, China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2015
First Posted
August 28, 2015
Study Start
September 1, 2015
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
August 28, 2015
Record last verified: 2015-08