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

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ClinicalTrials.gov Identifier: NCT02673853
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Postoperative Complications

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.

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Study Type : Observational
Actual Enrollment : 337 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
Study Start Date : February 2016
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673853


Locations
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Singapore
National University Health System
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Lian Kah Ti, MBBS, MMed National University Health System (NUHS)
Publications:
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02673853    
Other Study ID Numbers: 2015/00055
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National University Hospital, Singapore:
Supraglottic airway
Mini-dose atracurium
Postoperative residual paralysis
Additional relevant MeSH terms:
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Paralysis
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms