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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02635802
• Other study ID #: zdyfysicu-1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 6, 2015
• Last updated: December 16, 2015
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2015
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University	Yichang Humanwell Pharmaceutical Co.,Ltd

References & Publications (10)

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 2 — View Citation

Battershill AJ, Keating GM. Remifentanil : a review of its analgesic and sedative use in the intensive care unit. Drugs. 2006;66(3):365-85. Review. — View Citation

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): — View Citation

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. E — View Citation

Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. — View Citation

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; — View Citation

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 random — View Citation

Soltész S, Biedler A, Silomon M, Schöpflin 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. — View Citation

Wilhelm W, Dorscheid E, Schlaich N, Niederprüm P, Deller D. [The use of remifentanil in critically ill patients. Clinical findings and early experience]. Anaesthesist. 1999 Sep;48(9):625-9. German. — View Citation

Wilhelm W, Kreuer S. The place for short-acting opioids: special emphasis on remifentanil. Crit Care. 2008;12 Suppl 3:S5. doi: 10.1186/cc6152. Epub 2008 May 14. Review. — View Citation

Outcome

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