search
Back to results

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

Primary Purpose

Spinal Diseases, Local Anesthesia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Lidocaine
Low-dose Dexmedetomidine
Moderate-dose Dexmedetomidine
High-dose Dexmedetomidine
normal saline
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Diseases focused on measuring dexmedetomidine, prone position, spine surgery, Minimally invasive, local anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 ;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Low-dose Dexmedetomidine

    Moderate-dose Dexmedetomidine

    High-dose Dexmedetomidine

    normal saline Control group

    Arm 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

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    Ramsay sedation score
    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
    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
    The patient and the surgeon satisfaction
    four grades：Very satisfied; General satisfied; Not satisfied; Very dissatisfied

    Full Information

    First Posted
    August 20, 2015
    Last Updated
    August 25, 2015
    Sponsor
    Tang-Du Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02535273
    Brief Title
    The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tang-Du Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Diseases, Local Anesthesia
    Keywords
    dexmedetomidine, prone position, spine surgery, Minimally invasive, local anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    212 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-dose Dexmedetomidine
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Moderate-dose Dexmedetomidine
    Arm Type
    Experimental
    Arm 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
    Arm Title
    High-dose Dexmedetomidine
    Arm Type
    Experimental
    Arm 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
    Arm Title
    normal saline Control group
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    Yisi
    Intervention Description
    load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Other Intervention Name(s)
    Lidocaine Hydrochloride Injection
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Low-dose Dexmedetomidine
    Other Intervention Name(s)
    Yisi
    Intervention Description
    maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Moderate-dose Dexmedetomidine
    Other Intervention Name(s)
    Yisi
    Intervention Description
    maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    High-dose Dexmedetomidine
    Other Intervention Name(s)
    Yisi
    Intervention Description
    maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    Sodium Chloride Physiological Solution
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Ramsay sedation score
    Description
    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.
    Time Frame
    From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
    Title
    visual analogue scale
    Description
    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.
    Time Frame
    From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
    Secondary Outcome Measure Information:
    Title
    The total amount of lidocaine
    Time Frame
    2h after surgery；
    Title
    The patient and the surgeon satisfaction
    Description
    four grades：Very satisfied; General satisfied; Not satisfied; Very dissatisfied
    Time Frame
    2h after surgery；

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 ;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sun Li
    Organizational Affiliation
    Air Force Military Medical University, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23741555
    Citation
    Nakamura Y, Yabuki S, Kikuchi S, Konno S. Minimally invasive surgery for osteoid osteoma of the cervical spine using microendoscopic discectomy system. Asian Spine J. 2013 Jun;7(2):143-7. doi: 10.4184/asj.2013.7.2.143. Epub 2013 May 22.
    Results Reference
    background
    PubMed Identifier
    23793558
    Citation
    Smith N, Masters J, Jensen C, Khan A, Sprowson A. Systematic review of microendoscopic discectomy for lumbar disc herniation. Eur Spine J. 2013 Nov;22(11):2458-65. doi: 10.1007/s00586-013-2848-8. Epub 2013 Jun 23.
    Results Reference
    background
    PubMed Identifier
    23873279
    Citation
    Yoshimoto M, Takebayashi T, Ida K, Tanimoto K, Yamashita T. Microendoscopic discectomy in athletes. J Orthop Sci. 2013 Nov;18(6):902-8. doi: 10.1007/s00776-013-0442-x. Epub 2013 Jul 20.
    Results Reference
    background
    PubMed Identifier
    22415380
    Citation
    Gandhi SD, Anderson DG. Minimally invasive surgery for the lumbar spine. J Neurosurg Sci. 2012 Mar;56(1):27-34.
    Results Reference
    background
    PubMed Identifier
    23299723
    Citation
    Arts MP. Reply to the letter to the editor of R. Q. Knight concerning "does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial" by M. Arts, R. Brand, et al. (2011) Eur Spine J 20(1):51-57. doi:10.1007/s00586-012-2491-9. Eur Spine J. 2013 Apr;22(4):899. doi: 10.1007/s00586-012-2643-y. Epub 2013 Jan 9. No abstract available.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs