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The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01545193
First received: March 1, 2012
Last updated: April 3, 2015
Last verified: April 2015
Results First Received: March 17, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Residual Neuromuscular Blockade in Elderly Patients
Intervention: Other: Age and incidence of residual neuromuscular blockade

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Age 18-50

This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade

Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade

Age 70-90

This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade

Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade


Participant Flow:   Overall Study
    Age 18-50   Age 70-90
STARTED   150   150 
COMPLETED   150   149 
NOT COMPLETED   0   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Age 18-50

This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade

Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade

Age 70-90

This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade

Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade

Total Total of all reporting groups

Baseline Measures
   Age 18-50   Age 70-90   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   149   299 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   150   0   150 
>=65 years   0   149   149 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 38 
 (30 to 46) 
 75 
 (72 to 80) 
 57 
 (51 to 63) 
Gender 
[Units: Participants]
     
Female   98   84   182 
Male   52   65   117 
Region of Enrollment 
[Units: Participants]
     
United States   150   149   299 


  Outcome Measures
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1.  Primary:   Incidence of Residual Neuromuscular Blockade   [ Time Frame: Early postoperative period, up to 24 hours ]

2.  Secondary:   Signs and Symptoms of Residual Neuromuscular Blockade   [ Time Frame: Early postoperative period, up to 24 hours ]

3.  Secondary:   Respiratory Events Potentially Related to Residual Neuromuscular Blockade   [ Time Frame: Early postoperative period, up to 24 hours ]

4.  Secondary:   PACU Length of Stay   [ Time Frame: Early postoperative period, up to 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Glenn S. Murphy,MD
Organization: NorthShore University HealthSystem
phone: 847-570-2760
e-mail: dgmurphy2@yahoo.com



Responsible Party: Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01545193     History of Changes
Other Study ID Numbers: EH11-045
Study First Received: March 1, 2012
Results First Received: March 17, 2015
Last Updated: April 3, 2015