Clinical trial NCT03665805: Postoperative Residual Curarization in 2018
Official title: Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Residual Curarization
Keywords: Muscle Relaxation
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 587
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: About 600 surgical patients (the first 600 inpatients and outpatients scheduled for anesthesia during the study period who meet the study criteria).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative residual curarisation
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
Study officials:
References:
citation: 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. doi: 10.1213/01.ane.0000195543.61123.1f.
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. doi: 10.1177/0310057X1204000611.