the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
NCT ID: NCT02635802
Last Updated: 2015-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1500 participants
INTERVENTIONAL
2015-12-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Remifentanil
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.
Remifentanil
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.
Midazolam
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.
Lidocaine
injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
Lidocaine
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.
Midazolam
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.
Remifentanil+Lidocaine
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
Remifentanil+Lidocaine
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.
Midazolam
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.
Interventions
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Remifentanil
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.
Lidocaine
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.
Remifentanil+Lidocaine
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.
Midazolam
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.
Eligibility Criteria
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Inclusion Criteria
* tracheotomy
* central venous puncture
* pleural puncture
* abdominal puncture
* lumbar puncture
* bone marrow puncture
* fiber bronchoscopic examination
* other small short-time operations
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Yichang Humanwell Pharmaceutical Co., Ltd., China
INDUSTRY
The First Affiliated Hospital of Zhengzhou University
OTHER
Responsible Party
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Rongqi Sun
The director of SICU,Chief physician,professor
References
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Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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zdyfysicu-1
Identifier Type: -
Identifier Source: org_study_id