The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia
Phase 4
- Conditions
- Spinal DiseasesLocal Anesthesia
- Interventions
- Registration Number
- NCT02535273
- Lead Sponsor
- Tang-Du Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 212
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 ;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose Dexmedetomidine Dexmedetomidine 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 Low-dose Dexmedetomidine Low-dose Dexmedetomidine 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 Moderate-dose Dexmedetomidine Dexmedetomidine 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 High-dose Dexmedetomidine Dexmedetomidine 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 High-dose Dexmedetomidine High-dose Dexmedetomidine 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 normal saline Control group normal saline 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 Moderate-dose Dexmedetomidine Moderate-dose Dexmedetomidine 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 Low-dose Dexmedetomidine Lidocaine 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 Moderate-dose Dexmedetomidine Lidocaine 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 High-dose Dexmedetomidine Lidocaine 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 normal saline Control group Lidocaine 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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