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

Phase 4

• Conditions: Critical Illness
• Interventions: Drug: Remifentanil+Lidocaine; Drug: Remifentanil; Drug: Lidocaine; Drug: Midazolam

• Registration Number: NCT02635802
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-06
• Study First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Study First Posted: 2015-12-21
• Last Update Posted: 2015-12-21
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil+Lidocaine	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	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	Midazolam	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	Lidocaine	injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
Lidocaine	Midazolam	injection form concentration 10mg/ml loading dose 100-400mg local anesthesia
Remifentanil+Lidocaine	Midazolam	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

Primary Outcome Measures

Name	Time	Method
vital signs change	baseline, intraoperative and 10mins after operation	Richmond Agitation-Sedation Scale(RASS)

Secondary Outcome Measures

Name	Time	Method
number of adverse reaction	baseline,intraoperative,10mins after operation,30mins after operation	respiratory depression,skeletal muscle stiffness,nausea vomting and dizziness,hypertension,allergy,bradycardia etc.