Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion

Postoperative Complications Clinical Trial

Official title:

Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673853
• Other study ID #: 2015/00055
• Status: Completed
• Start date: February 2016
• Est. completion date: March 16, 2018

Study information

• Verified date: August 2018
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: March 16, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Postoperative Complications

Locations

Country	Name	City	State
Singapore	National University Health System	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. Review. — View Citation

Fortier LP, McKeen D, Turner K, de Médicis É, 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9	Measuring the extent of operative paralysis using established methods such as the train of four (TOF) with ratio of <0.9 indicating inadequate recovery, Double burst stimulation, acceleromyography, five second head lift and tongue depressor test. The relevant data about the patient's condition will be collected and filled up in the data collection form.	Through study completion, up to 4 months