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Completed

NCT Number: NCT02673853

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

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.

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Health System

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2016
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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