Postoperative Residual Curarization in 2018

Postoperative Residual Curarization Clinical Trial

Official title:

Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665805
• Other study ID #: LKGC2018
• Status: Completed
• Start date: July 30, 2018
• Est. completion date: November 12, 2018

Study information

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

Clinical Trial Summary

The primary objective of this study is to evaluate the incidence of postoperative residual curarization, as defined by a train-of-four <90%, upon postanaesthesia care unit arrival. Anesthetists tend to use train-of-four monitoring in the operating theatre to interpret muscle tone. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. Hypothesizing a change in our practice since 2006-2012 (Cammu G, Anesth Analg 2006; 102: 426-9 and Cammu G, Anaesth Intensive Care 2012; 40: 999-1006), residual neuromuscular block as well as the use of intraoperative neuromuscular transmission monitoring and reversal of neuromuscular blocking agents will again be prospectively evaluated in 2018. The present study aims to compare these three periods (2006-2012-2018) in terms of management of neuromuscular block in the operating room and to look for a relationship with the incidence of postoperative residual curarization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: November 12, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older;

• Informed consent signed;

• Admission for elective surgery;

• Administration of non-depolarizing neuromuscular blocking agents during surgery;

• Tracheal intubation

Exclusion Criteria:

• Evidence of renal, hepatic, metabolic, and/or neuromuscular disorders

• Ejection fraction <20%

• Admission for emergency surgery; or cardiothoracic surgery

• Reoperation during the same hospital admission

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Postoperative Residual Curarization

Intervention

Other:
• neuromuscular transmission monitoring
The acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of the TOFscan neuromuscular transmission monitor (iDMed, Marseille, France).

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 (2)

Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. — View Citation

Cammu GV, Smet V, De Jongh K, Vandeput D. A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery. Anaesth Intensive Care. 2012 Nov;40(6):999-1006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative residual curarisation	Incidence of postoperative residual curarisation defined by a train-of-four (TOF) ratio < 0,9 at post-anesthesia care unit arrival	Immediately after the patients' arrival in the post-anesthesia care unit (<5 min after arrival), two consecutive neuromuscular transmission measurements (separated by 15 s) will be obtained, and the average of the 2 values will be recorded.