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

Tang-Du Hospital

Status and phase: Unknown; Phase 4

Conditions: Local Anesthesia; Spinal Diseases

Treatments: Drug: Dexmedetomidine; Drug: Moderate-dose Dexmedetomidine; Drug: Lidocaine; Drug: High-dose Dexmedetomidine; Drug: Low-dose Dexmedetomidine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02535273

Tangdu-dex-loc

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 4 patient groups, including a placebo group

Low-dose Dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Low-dose Dexmedetomidine

Drug: Lidocaine

Drug: Dexmedetomidine

Moderate-dose Dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine

Drug: Moderate-dose Dexmedetomidine

Drug: Dexmedetomidine

High-dose Dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: High-dose Dexmedetomidine

Drug: Lidocaine

Drug: Dexmedetomidine

normal saline Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline

Drug: Lidocaine