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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Drug: Remifentanil; Drug: Midazolam; Drug: Lidocaine; Drug: Remifentanil+Lidocaine

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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: 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.
Experimental: Lidocaine; injection form concentration 10mg/ml loading dose 100-400mg local anesthesia	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.; 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.
Experimental: 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	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vital signs change	heart rate, respiration rate	baseline, intraoperative and 10mins after operation
vital signs change	respiration rate	baseline, intraoperative and 10mins after operation
vital signs change	blood oxygen saturation of artery blood of finger(SpO2)	baseline, intraoperative and 10mins after operation
vital signs change	mean blood pressure	baseline, intraoperative and 10mins after operation
vital signs change	Critical-Care Observation Tool(CPOT)	baseline, intraoperative and 10mins after operation
vital signs change	Richmond Agitation-Sedation Scale(RASS)	baseline, intraoperative and 10mins after operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Yichang Humanwell Pharmaceutical Co., Ltd., China

Publications and helpful links

General Publications

• Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. No abstract available.
• Soltesz S, Biedler A, Silomon M, Schopflin I, Molter GP. Recovery after remifentanil and sufentanil for analgesia and sedation of mechanically ventilated patients after trauma or major surgery. Br J Anaesth. 2001 Jun;86(6):763-8. doi: 10.1093/bja/86.6.763.
• Wilhelm W, Dorscheid E, Schlaich N, Niederprum P, Deller D. [The use of remifentanil in critically ill patients. Clinical findings and early experience]. Anaesthesist. 1999 Sep;48(9):625-9. doi: 10.1007/s001010050762. German.
• Wilhelm W, Kreuer S. The place for short-acting opioids: special emphasis on remifentanil. Crit Care. 2008;12 Suppl 3(Suppl 3):S5. doi: 10.1186/cc6152. Epub 2008 May 14.
• Casey E, Lane A, Kuriakose D, McGeary S, Hayes N, Phelan D, Buggy D. Bolus remifentanil for chest drain removal in ICU: a randomized double-blind comparison of three modes of analgesia in post-cardiac surgical patients. Intensive Care Med. 2010 Aug;36(8):1380-5. doi: 10.1007/s00134-010-1836-2. Epub 2010 Mar 18.
• Chalumeau-Lemoine L, Stoclin A, Billard V, Laplanche A, Raynard B, Blot F. Flexible fiberoptic bronchoscopy and remifentanil target-controlled infusion in ICU: a preliminary study. Intensive Care Med. 2013 Jan;39(1):53-8. doi: 10.1007/s00134-012-2697-7. Epub 2012 Sep 28.
• Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.
• Futier E, Chanques G, Cayot Constantin S, Vernis L, Barres A, Guerin R, Chartier C, Perbet S, Petit A, Jabaudon M, Bazin JE, Constantin JM. Influence of opioid choice on mechanical ventilation duration and ICU length of stay. Minerva Anestesiol. 2012 Jan;78(1):46-53. Epub 2011 Nov 5.
• Battershill AJ, Keating GM. Remifentanil : a review of its analgesic and sedative use in the intensive care unit. Drugs. 2006;66(3):365-85. doi: 10.2165/00003495-200666030-00013.
• Karabinis A, Mandragos K, Stergiopoulos S, Komnos A, Soukup J, Speelberg B, Kirkham AJ. Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308]. Crit Care. 2004 Aug;8(4):R268-80. doi: 10.1186/cc2896. Epub 2004 Jun 28.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: analgesia; intensive care units; remifentanil
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Remifentanil; Midazolam; Lidocaine
• Other Study ID Numbers: zdyfysicu-1