search
Back to results

the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Remifentanil
Lidocaine
Remifentanil+Lidocaine
Midazolam
Sponsored by
The First Affiliated Hospital of Zhengzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring remifentanil, analgesia, intensive care units

Eligibility Criteria

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

Inclusion Criteria:

  • critically ill patients need endotracheal intubation
  • tracheotomy
  • central venous puncture
  • pleural puncture
  • abdominal puncture
  • lumbar puncture
  • bone marrow puncture
  • fiber bronchoscopic examination
  • other small short-time operations

Exclusion Criteria:

  • patients allergic to opioids
  • in pregnancy or in feeding
  • with myasthenia gravis
  • with hypovolemia,
  • take monoamine oxidase inhibitor(MAOI) in 14days
  • in coma and GCS<8
  • with bradycardia or hypotension

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Remifentanil

    Lidocaine

    Remifentanil+Lidocaine

    Arm Description

    injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished.

    injection form concentration 10mg/ml loading dose 100-400mg local anesthesia

    injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished + injection form concentration 10mg/ml loading dose 100-400mg local anesthesia

    Outcomes

    Primary Outcome Measures

    vital signs change
    heart rate, respiration rate
    vital signs change
    respiration rate
    vital signs change
    blood oxygen saturation of artery blood of finger(SpO2)
    vital signs change
    mean blood pressure
    vital signs change
    Critical-Care Observation Tool(CPOT)
    vital signs change
    Richmond Agitation-Sedation Scale(RASS)

    Secondary Outcome Measures

    number of adverse reaction
    respiratory depression,skeletal muscle stiffness,nausea vomting and dizziness,hypertension,allergy,bradycardia etc.

    Full Information

    First Posted
    December 6, 2015
    Last Updated
    December 16, 2015
    Sponsor
    The First Affiliated Hospital of Zhengzhou University
    Collaborators
    Yichang Humanwell Pharmaceutical Co., Ltd., China
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02635802
    Brief Title
    the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
    Official Title
    the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Affiliated Hospital of Zhengzhou University
    Collaborators
    Yichang Humanwell Pharmaceutical Co., Ltd., China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. Remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in ICU small short time operation.The purpose of this study is to determine (1) whether remifentanil is effective in small short time operations in ICU or not, (2) the save range of remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens in these operations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness
    Keywords
    remifentanil, analgesia, intensive care units

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Remifentanil
    Arm Type
    Experimental
    Arm Description
    injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished.
    Arm Title
    Lidocaine
    Arm Type
    Experimental
    Arm Description
    injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
    Arm Title
    Remifentanil+Lidocaine
    Arm Type
    Experimental
    Arm Description
    injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished + injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Description
    a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h pumping if the operation can not be done in 5 minutes. Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after the loading.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5 μg/kg·h every 2-5min.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    lidocaine 100-400mg,local anesthesia.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after local anesthesia.We should maintain the CPOT≤2 and RASS 0～2.
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil+Lidocaine
    Intervention Description
    a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h remifentanil pumping immediately if the operation can not be done in 5 minutes.then local anesthesia with lidocaine 100-400mg.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after anesthesia.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5μg/kg·h every 2-5min.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Intervention Description
    midazolam is an adjuvant drug.we should maintain the CPOT≤2 and RASS 0～2,if lidocaine is already used up to 400mg or the pumping rate of remifentanil is already 7.5μg/kg·h,then we should use midazolam 3mg, intravenous injection slowly.
    Primary Outcome Measure Information:
    Title
    vital signs change
    Description
    heart rate, respiration rate
    Time Frame
    baseline, intraoperative and 10mins after operation
    Title
    vital signs change
    Description
    respiration rate
    Time Frame
    baseline, intraoperative and 10mins after operation
    Title
    vital signs change
    Description
    blood oxygen saturation of artery blood of finger(SpO2)
    Time Frame
    baseline, intraoperative and 10mins after operation
    Title
    vital signs change
    Description
    mean blood pressure
    Time Frame
    baseline, intraoperative and 10mins after operation
    Title
    vital signs change
    Description
    Critical-Care Observation Tool(CPOT)
    Time Frame
    baseline, intraoperative and 10mins after operation
    Title
    vital signs change
    Description
    Richmond Agitation-Sedation Scale(RASS)
    Time Frame
    baseline, intraoperative and 10mins after operation
    Secondary Outcome Measure Information:
    Title
    number of adverse reaction
    Description
    respiratory depression,skeletal muscle stiffness,nausea vomting and dizziness,hypertension,allergy,bradycardia etc.
    Time Frame
    baseline,intraoperative,10mins after operation,30mins after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: critically ill patients need endotracheal intubation tracheotomy central venous puncture pleural puncture abdominal puncture lumbar puncture bone marrow puncture fiber bronchoscopic examination other small short-time operations Exclusion Criteria: patients allergic to opioids in pregnancy or in feeding with myasthenia gravis with hypovolemia, take monoamine oxidase inhibitor(MAOI) in 14days in coma and GCS<8 with bradycardia or hypotension

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9291773
    Citation
    Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. No abstract available.
    Results Reference
    result
    PubMed Identifier
    11573581
    Citation
    Soltesz S, Biedler A, Silomon M, Schopflin I, Molter GP. Recovery after remifentanil and sufentanil for analgesia and sedation of mechanically ventilated patients after trauma or major surgery. Br J Anaesth. 2001 Jun;86(6):763-8. doi: 10.1093/bja/86.6.763.
    Results Reference
    result
    PubMed Identifier
    10525595
    Citation
    Wilhelm W, Dorscheid E, Schlaich N, Niederprum P, Deller D. [The use of remifentanil in critically ill patients. Clinical findings and early experience]. Anaesthesist. 1999 Sep;48(9):625-9. doi: 10.1007/s001010050762. German.
    Results Reference
    result
    PubMed Identifier
    18495056
    Citation
    Wilhelm W, Kreuer S. The place for short-acting opioids: special emphasis on remifentanil. Crit Care. 2008;12 Suppl 3(Suppl 3):S5. doi: 10.1186/cc6152. Epub 2008 May 14.
    Results Reference
    result
    PubMed Identifier
    20237760
    Citation
    Casey E, Lane A, Kuriakose D, McGeary S, Hayes N, Phelan D, Buggy D. Bolus remifentanil for chest drain removal in ICU: a randomized double-blind comparison of three modes of analgesia in post-cardiac surgical patients. Intensive Care Med. 2010 Aug;36(8):1380-5. doi: 10.1007/s00134-010-1836-2. Epub 2010 Mar 18.
    Results Reference
    result
    PubMed Identifier
    23052952
    Citation
    Chalumeau-Lemoine L, Stoclin A, Billard V, Laplanche A, Raynard B, Blot F. Flexible fiberoptic bronchoscopy and remifentanil target-controlled infusion in ICU: a preliminary study. Intensive Care Med. 2013 Jan;39(1):53-8. doi: 10.1007/s00134-012-2697-7. Epub 2012 Sep 28.
    Results Reference
    result
    PubMed Identifier
    21040558
    Citation
    Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.
    Results Reference
    result
    PubMed Identifier
    21971434
    Citation
    Futier E, Chanques G, Cayot Constantin S, Vernis L, Barres A, Guerin R, Chartier C, Perbet S, Petit A, Jabaudon M, Bazin JE, Constantin JM. Influence of opioid choice on mechanical ventilation duration and ICU length of stay. Minerva Anestesiol. 2012 Jan;78(1):46-53. Epub 2011 Nov 5.
    Results Reference
    result
    PubMed Identifier
    16526829
    Citation
    Battershill AJ, Keating GM. Remifentanil : a review of its analgesic and sedative use in the intensive care unit. Drugs. 2006;66(3):365-85. doi: 10.2165/00003495-200666030-00013.
    Results Reference
    result
    PubMed Identifier
    15312228
    Citation
    Karabinis A, Mandragos K, Stergiopoulos S, Komnos A, Soukup J, Speelberg B, Kirkham AJ. Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308]. Crit Care. 2004 Aug;8(4):R268-80. doi: 10.1186/cc2896. Epub 2004 Jun 28.
    Results Reference
    result

    Learn more about this trial

    the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation

    We'll reach out to this number within 24 hrs