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

August 25, 2015 updated by: Tang-Du Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ramsay sedation score
Time Frame: 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.
From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
visual analogue scale
Time Frame: 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.
From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total amount of lidocaine
Time Frame: 2h after surgery；
2h after surgery；
The patient and the surgeon satisfaction
Time Frame: 2h after surgery；
four grades：Very satisfied; General satisfied; Not satisfied; Very dissatisfied
2h after surgery；

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Principal Investigator: Sun Li, Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Estimate)

August 28, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tangdu-dex-loc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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