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

Completed

• Conditions: Postoperative Complications

• Registration Number: NCT02673853
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Study First Submitted: 2016-01-04
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Primary Completion: 2018-03-08
• Study Completion: 2018-03-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9	Through study completion, up to 4 months	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.

Trial Locations

Locations (1)

National University Health System; 🇸🇬 Singapore, Singapore