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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Lidocaine
* Drug: Remifentanil+Lidocaine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil<br>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. | Drug: Remifentanil<br>* 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.<br>Drug: Midazolam<br>* 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.<br>|
| Experimental: Lidocaine<br>injection form concentration 10mg/ml loading dose 100-400mg local anesthesia | Drug: Lidocaine<br>* 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.<br>Drug: Midazolam<br>* 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.<br>|
| Experimental: Remifentanil+Lidocaine<br>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 | Drug: Remifentanil+Lidocaine<br>* 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.<br>Drug: Midazolam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs change | heart rate, respiration rate | baseline, intraoperative and 10mins after operation | 
| vital signs change | respiration rate | baseline, intraoperative and 10mins after operation | 
| vital signs change | blood oxygen saturation of artery blood of finger(SpO2) | baseline, intraoperative and 10mins after operation | 
| vital signs change | mean blood pressure | baseline, intraoperative and 10mins after operation | 
| vital signs change | Critical-Care Observation Tool(CPOT) | baseline, intraoperative and 10mins after operation | 
| vital signs change | Richmond Agitation-Sedation Scale(RASS) | baseline, intraoperative and 10mins after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse reaction | respiratory depression,skeletal muscle stiffness,nausea vomting and dizziness,hypertension,allergy,bradycardia etc. | baseline,intraoperative,10mins after operation,30mins after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remifentanil, analgesia, intensive care units