Postoperative Residual Paralysis After Cardiac Surgery

NCT03291184 | Completed

• 1 other identifier: EN_GC_2017
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Residual Curarization

Keywords

neuromuscular blockade; neuromuscular monitoring

Outcome Measures

Primary Outcomes (1)

• postoperative residual curarisation

  mean train-of-four \<90% as measured by neuromuscular blockade monitoring

  6 hours after arrival in the ICU

Interventions

peripheral neuromuscular monitor DEVICE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients admitted to the ICU after elective cardiac surgery

You may not qualify if:

• emergency cardiac surgery

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

Related Publications (3)

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

  PMID: 17486918 BACKGROUND

• 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.

  PMID: 21865491 BACKGROUND

• 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. doi: 10.1177/106002809603000211.

  PMID: 8835051 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GUY CAMMU

  Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant will still be under sedation at the moment of measuring neuromuscular blockade. The care provider will perform measurements, while the investigator is blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Staff Anesthesiologist

Model Details: Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: September 4, 2017
• Primary Completion: January 2, 2018
• Study Completion: March 8, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)