Clinical trial NCT02635802: the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
Official title: the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Critical Illness
Keywords: remifentanil
analgesia
intensive care units
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Yichang Humanwell Pharmaceutical Co., Ltd., China
First posted: 2015-12-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: vital signs change
timeFrame: baseline, intraoperative and 10mins after operation
measure: vital signs change
timeFrame: baseline, intraoperative and 10mins after operation
measure: vital signs change
timeFrame: baseline, intraoperative and 10mins after operation
measure: vital signs change
timeFrame: baseline, intraoperative and 10mins after operation
measure: vital signs change
timeFrame: baseline, intraoperative and 10mins after operation
measure: vital signs change
timeFrame: baseline, intraoperative and 10mins after operation
Secondary outcomes:
measure: number of adverse reaction
timeFrame: baseline,intraoperative,10mins after operation,30mins after operation
Other outcomes:
Locations:
Study officials:
References:
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