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

NCT02635802 | Unknown Phase 4 DMC

• 1 other identifier: zdyfysicu-1
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness

Keywords

remifentanil; analgesia; intensive care units

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• number of adverse reaction

  baseline,intraoperative,10mins after operation,30mins after operation

Study Arms (3)

Remifentanil

EXPERIMENTAL

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; Drug: Midazolam

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine; Drug: Midazolam

Remifentanil+Lidocaine

EXPERIMENTAL

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: Remifentanil+Lidocaine; Drug: Midazolam

Interventions

Remifentanil DRUG

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.

Remifentanil

Lidocaine DRUG

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.

Lidocaine

Remifentanil+Lidocaine DRUG

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.

Remifentanil+Lidocaine

Midazolam DRUG

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.

Lidocaine; Remifentanil; Remifentanil+Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (10)

• Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. No abstract available.

  PMID: 9291773 RESULT

• 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.

  PMID: 11573581 RESULT

• 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.

  PMID: 10525595 RESULT

• 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.

  PMID: 18495056 RESULT

• 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.

  PMID: 20237760 RESULT

• 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.

  PMID: 23052952 RESULT

• 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.

  PMID: 21040558 RESULT

• 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.

  PMID: 21971434 RESULT

• 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.

  PMID: 16526829 RESULT

• 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.

  PMID: 15312228 RESULT

MeSH Terms

Conditions

Critical Illness; Agnosia

Interventions

Remifentanil; Lidocaine; Midazolam

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of SICU,Chief physician,professor

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 21, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 21, 2015

Record last verified: 2015-12