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

Sponsor

Tang-Du Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02535273

Collaborator

(none)

212

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Diseases Local Anesthesia	Drug: Dexmedetomidine Drug: Lidocaine Drug: Low-dose Dexmedetomidine Drug: Moderate-dose Dexmedetomidine Drug: High-dose Dexmedetomidine Drug: normal saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 ;