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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

Tracking Information
First Submitted Date January 4, 2016
First Posted Date February 4, 2016
Last Update Posted Date August 27, 2018
Study Start Date February 2016
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2018)
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.
Original Primary Outcome Measures
 (submitted: February 1, 2016)
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 ]
There has been various objective and subject methods of 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
Official Title Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Postoperative Complications
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 23, 2018)
337
Original Estimated Enrollment
 (submitted: February 1, 2016)
400
Actual Study Completion Date March 16, 2018
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT02673853
Other Study ID Numbers 2015/00055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor National University Hospital, Singapore
Collaborators Not Provided
Investigators
Principal Investigator: Lian Kah Ti, MBBS, MMed National University Health System (NUHS)
PRS Account National University Hospital, Singapore
Verification Date August 2018