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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02635802

Enrollment

1500

Registered

2015-12-21

Start date

2015-12-31

Completion date

2016-09-30

Last updated

2015-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

remifentanil, analgesia, intensive care units

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.

Interventions

DRUGRemifentanil

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.

DRUGLidocaine

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.

DRUGRemifentanil+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.

DRUGMidazolam

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
vital signs change	baseline, intraoperative and 10mins after operation	heart rate, respiration rate

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026