Postoperative Residual Curarization in 2018

NCT03665805 | Completed

• 1 other identifier: LKGC2018
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Residual Curarization

Keywords

Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

neuromuscular transmission monitoring OTHER

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).

Eligibility Criteria

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

You may qualify if:

• years of age or older;
• Informed consent signed;
• Admission for elective surgery;
• Administration of non-depolarizing neuromuscular blocking agents during surgery;
• Tracheal intubation

You may not qualify if:

• 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

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

Related 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. doi: 10.1213/01.ane.0000195543.61123.1f.

  PMID: 16428537 BACKGROUND

• 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.

  PMID: 23194209 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: July 30, 2018
• Primary Completion: October 31, 2018
• Study Completion: November 12, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)