NCT02535273

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2015-08-28
• Last updated: 2015-08-28