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The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT01450813
First received: September 22, 2011
Last updated: April 4, 2017
Last verified: April 2017
Results First Received: March 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Participant, Investigator;   Primary Purpose: Basic Science
Conditions: Anesthesia
Neuromuscular Blockade
Interventions: Drug: Saline 0.06 ml/kg
Drug: Rocuronium 0.2 mg/kg
Drug: Rocuronium 0.4 mg/kg
Drug: Rocuronium 0.6 mg/kg

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 Saline 0.06 ml/kg
Group 2 Rocuronium 0.2 mg/kg
Group 3 Rocuronium 0.4 mg/kg
Group 4 Rocuronium 0.6 mg/kg

Participant Flow:   Overall Study
    Group 1   Group 2   Group 3   Group 4
STARTED   20   20   20   20 
COMPLETED   19   19   20   17 
NOT COMPLETED   1   1   0   3 
Physician Decision                1                1                0                3 



  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.
No text entered.

Reporting Groups
  Description
Group 1 Rocuronium dose 0 mg/kg prior to laryngoscopy
Group 2 Rocuronium dose 0.2 mg/kg prior to laryngoscopy
Group 3 Rocuronium dose 0.4 mg/kg prior to laryngoscopy
Group 4 Rocuronium dose 0.6 mg/kg prior to laryngoscopy
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Group 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   20   17   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.9  (12.3)   38.6  (14.6)   39.4  (12.7)   32.9  (6.4)   37.9  (11.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      9  47.4%      8  42.1%      8  40.0%      9  52.9%      34  45.3% 
Male      10  52.6%      11  57.9%      12  60.0%      8  47.1%      41  54.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups   [ Time Frame: Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention ]

2.  Secondary:   The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups   [ Time Frame: Maintenance Anesthesia ]


  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
Sample size for this study calculation was based upon the assumption that that the expected mean of CVI would be 60 with a variance of 30 and that the variance of 30 would be equal for each group.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Donald Mathews, M.D.
Organization: Fletcher Allen Health Care at The University of Vermont
phone: (802) 847-2415
e-mail: Donald.Mathews@vtmednet.org



Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01450813     History of Changes
Other Study ID Numbers: COVMOPR0176
Study First Received: September 22, 2011
Results First Received: March 10, 2016
Last Updated: April 4, 2017