Postoperative Residual Paralysis After Cardiac Surgery

Postoperative Residual Curarization Clinical Trial

Official title:

Is Postoperative Residual Curarisation Still an Issue at the Moment of Weaning of the ICU Patient Following Cardiac Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291184
• Other study ID #: EN_GC_2017
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: April 9, 2018
• Start date: September 4, 2017
• Est. completion date: March 8, 2018

Study information

• Verified date: March 2018
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to describe the incidence of postoperative residual paralysis (mean train-of-four <90%) when weaning from the ventilator in patients admitted to the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will perform a measurement of the train-of-four at the thumb with a neuromuscular transmission monitor. Every value below 90% will be considered as residual paralysis and treated appropriately by means of a reversal agent.

Description:

Postoperatively, in the ICU, readiness-for-weaning is based on ICU doctor-nurse-driven institutional weaning guidelines: 6 hours after arrival in the ICU, a patient who is normothermic, hemodynamically stable, has normal blood gasses and absence of residual bleeding. The ICU nurse caring for the patient will start weaning the patient from the ventilator, following these departmental guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 8, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients admitted to the ICU after elective cardiac surgery

Exclusion Criteria:

• emergency cardiac surgery

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Postoperative Residual Curarization

Intervention

Device:
• peripheral neuromuscular monitor
Residual paralysis can only be measured by neuromuscular transmission monitoring of a peripheral nerve, typically the ulnar nerve innervating the adductor pollicis muscle.

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Cammu G. How rational is muscle relaxation during cardiac surgery? Acta Anaesthesiol Belg. 2007;58(1):7-14. — View Citation

Rudis MI, Guslits BG, Zarowitz BJ. Technical and interpretive problems of peripheral nerve stimulation in monitoring neuromuscular blockade in the intensive care unit. Ann Pharmacother. 1996 Feb;30(2):165-72. Review. — View Citation

Videira RL, Vieira JE. What rules of thumb do clinicians use to decide whether to antagonize nondepolarizing neuromuscular blocking drugs? Anesth Analg. 2011 Nov;113(5):1192-6. doi: 10.1213/ANE.0b013e31822c986e. Epub 2011 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative residual curarisation	mean train-of-four <90% as measured by neuromuscular blockade monitoring	6 hours after arrival in the ICU