NCT02635802

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2015-12-21
• Last updated: 2015-12-21