Trial | NCT02635802  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    1500
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.
Study Started
Dec 31
2015
Primary Completion
Jun 30
2016
Anticipated
Study Completion
Sep 30
2016
Anticipated
Last Update
Dec 21
2015
Estimate

Drug 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.

Drug 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.

Drug 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.

Drug 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 Experimental

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.

Lidocaine Experimental

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

Remifentanil+Lidocaine Experimental

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

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
No Results Posted