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

Zhengzhou University

Status and phase: Unknown; Phase 4

Conditions: Critical Illness

Treatments: Drug: Remifentanil; Drug: Remifentanil+Lidocaine; Drug: Lidocaine; Drug: Midazolam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02635802

zdyfysicu-1

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups

Remifentanil

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Midazolam

Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine

Drug: Midazolam

Remifentanil+Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Remifentanil+Lidocaine

Drug: Midazolam