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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
212
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
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.
Time frame: 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.
Time frame: From 1min before dexmedetomidine infusion to 2h after surgery,up to 4 hours
The total amount of lidocaine
Time frame: 2h after surgery;
The patient and the surgeon satisfaction
four grades:Very satisfied; General satisfied; Not satisfied; Very dissatisfied
Time frame: 2h after surgery;
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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