Clinical trial NCT02673853: Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
Official title: Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: Supraglottic airway
Mini-dose atracurium
Postoperative residual paralysis
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 337
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be picked from all patients who are going surgery at National University Hospital (NUH) during the period of data collection, and who are receiving supraglottic airway for their procedure. They must fulfil the inclusion and exclusion criteria.

Brief summary: This study aims to establish the incidence of residual paralysis in patients following administration of a mini- dose of atracurium (less than ED95 i.e. \<0.23mg/kg or \<15 mg in most patients) during supraglottic airway insertion and correlate it with the duration of time from drug administration to arrival at PACU. The secondary aim is to compare the incidence of residual paralysis in patients who receive full doses of atracurium (per body weight) with those who receive mini-doses.

Detailed description: Post-operative residual paralysis may be defined as the incomplete recovery of muscle function following intra-operative administration of neuromuscular blockers (NMBs). This condition is associated with many negative patient outcomes such as: increased risk of aspiration; upper airway obstruction; and delayed Post-Anaesthetic Care Unit (PACU) discharge, amongst others. Despite the increasing use of shorter acting agents, the prevalence of residual paralysis in the PACU remains high at 20-50%. NMBs are commonly used to facilitate endotracheal intubation and insertion of the supraglottic airway by obtunding airway reflexes. Given the increasing use of mini-dose NMBs without post-operative reversal in clinical practice, there is a need to evaluate the incidence of residual paralysis in the patient population who have received mini-dose atracurium during the supraglottic airway insertion.

Eligibility criteria: Inclusion Criteria:

* Adults above 21 years old
* Received either a mini-dose of atracurium or full dose of atracurium during the placement of the supraglottic airway
* Did not receive any neuromuscular reversal agent at any point of the operation.

Exclusion Criteria:

* Patients with underlying neuromuscular disease
* Patients who received pre-operative medication that may affect neuromuscular transmission
* Patients who required additional doses of neuromuscular blockade at any point of the operation

Primary outcomes:
measure: Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9
timeFrame: Through study completion, up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Health System
Study officials:
affiliation: National University Health System (NUHS)
name: Lian Kah Ti, MBBS, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plaud B. Neuromuscular monitoring, residual blockade, and reversal: time for re-evaluation of our clinical practice. Can J Anaesth. 2013 Jul;60(7):634-40. doi: 10.1007/s12630-013-9952-4. Epub 2013 May 10. No abstract available.
citation: Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
citation: Donati F. Residual paralysis: a real problem or did we invent a new disease? Can J Anaesth. 2013 Jul;60(7):714-29. doi: 10.1007/s12630-013-9932-8. Epub 2013 Apr 27.