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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02673853
Enrollment
337
Registered
2016-02-04
Start date
2016-02-29
Completion date
2018-03-16
Last updated
2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Supraglottic airway, Mini-dose atracurium, Postoperative residual paralysis

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.

Interventions

None listed

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9Through study completion, up to 4 monthsMeasuring 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.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026