Local Anesthesia, Spinal Diseases
Conditions
Keywords
dexmedetomidine, prone position, spine surgery, Minimally invasive, local anesthesia
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.
Interventions
DRUGDexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
DRUGLidocaine
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
DRUGModerate-dose Dexmedetomidine
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
DRUGnormal 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
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 ;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ramsay sedation score | From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours | 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. |
| visual analogue scale | From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total amount of lidocaine | 2h after surgery； | — |
| The patient and the surgeon satisfaction | 2h after surgery； | four grades：Very satisfied; General satisfied; Not satisfied; Very dissatisfied |
Outcome results
None listed