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

NCT02535273 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2015-08-28

No results posted yet for this study

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.

Conditions

  • Spinal Diseases
  • Local Anesthesia

Interventions

DRUG

Dexmedetomidine

load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.

DRUG

Lidocaine

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

DRUG

Low-dose Dexmedetomidine

maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery

DRUG

Moderate-dose Dexmedetomidine

maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery

DRUG

High-dose Dexmedetomidine

maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery

DRUG

normal 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 & Collaborators

  • Tang-Du Hospital

    lead OTHER

Principal Investigators

  • Sun Li · Air Force Military Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-08-31
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535273 on ClinicalTrials.gov