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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Diseases, Local Anesthesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Lidocaine
* Drug: Low-dose Dexmedetomidine
* Drug: Moderate-dose Dexmedetomidine
* Drug: High-dose Dexmedetomidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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 ;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose Dexmedetomidine<br>load 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 | Drug: Dexmedetomidine<br>* load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.<br>* Other names: Yisi;Drug: Lidocaine<br>* 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<br>* Other names: Lidocaine Hydrochloride Injection;Drug: Low-dose Dexmedetomidine<br>* maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery<br>* Other names: Yisi;|
| Experimental: Moderate-dose Dexmedetomidine<br>load 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 | Drug: Dexmedetomidine<br>* load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.<br>* Other names: Yisi;Drug: Lidocaine<br>* 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<br>* Other names: Lidocaine Hydrochloride Injection;Drug: Moderate-dose Dexmedetomidine<br>* maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery<br>* Other names: Yisi;|
| Experimental: High-dose Dexmedetomidine<br>load 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 | Drug: Dexmedetomidine<br>* load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.<br>* Other names: Yisi;Drug: Lidocaine<br>* 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<br>* Other names: Lidocaine Hydrochloride Injection;Drug: High-dose Dexmedetomidine<br>* maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery<br>* Other names: Yisi;|
| Placebo Comparator: normal saline Control group<br>Intravenous 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 | Drug: Lidocaine<br>* 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<br>* Other names: Lidocaine Hydrochloride Injection;Drug: normal saline<br>* 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<br>* Other names: Sodium Chloride Physiological Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total amount of lidocaine |  | 2h after surgery； | 
| The patient and the surgeon satisfaction | four grades：Very satisfied; General satisfied; Not satisfied; Very dissatisfied | 2h after surgery； | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, prone position, spine surgery, Minimally invasive, local anesthesia