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

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ClinicalTrials.gov Identifier: NCT01450813
Recruitment Status : Completed
First Posted : October 12, 2011
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (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
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description Saline 0.06 ml/kg Rocuronium 0.2 mg/kg Rocuronium 0.4 mg/kg Rocuronium 0.6 mg/kg
Period Title: Overall Study
Started 20 20 20 20
Completed 19 19 20 17
Not Completed 1 1 0 3
Reason Not Completed
Physician Decision             1             1             0             3
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Total
Hide Arm/Group Description Rocuronium dose 0 mg/kg prior to laryngoscopy Rocuronium dose 0.2 mg/kg prior to laryngoscopy Rocuronium dose 0.4 mg/kg prior to laryngoscopy Rocuronium dose 0.6 mg/kg prior to laryngoscopy Total of all reporting groups
Overall Number of Baseline Participants 19 19 20 17 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 20 participants 17 participants 75 participants
35.9  (12.3) 38.6  (14.6) 39.4  (12.7) 32.9  (6.4) 37.9  (11.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 20 participants 17 participants 75 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%
1.Primary Outcome
Title The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups
Hide Description

The difference between the mean CVI in three minutes prior to laryngoscopy and three minutes following laryngoscopy reported as the mean change in CVI and the +/- 95% confidence interval for each group.

The Composite Variability Index (CVI) scale is a logistic regression of three measures of processed electroencephalography (EEG) signals. These signals are Bispectral Index (BIS), the variability of electromyelogram (sEMG), and the variability of BIS (sBIS). The scale ranges from 0 to 100 where a lower CVI value represents a lower likelihood of intraoperative somatic responses, and a higher CVI value represents a higher likelihood of intraoperative somatic responses.

Time Frame Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
Rocuronium 0mg/kg
Rocuronium 0.2mg/kg
Rocuronium 0.4mg/kg
Rocuronium 0.6mg/kg
Overall Number of Participants Analyzed 20 19 20 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.40
(2.15 to 2.64)
1.39
(0.95 to 1.83)
0.48
(0.24 to 0.72)
0.17
(-0.04 to 0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size needed for a one-way ANOVA test with an alpha of 0.05 and power of 0.8 to rule out the null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence was a total of 64 or 16 per Group.
Statistical Test of Hypothesis P-Value < 0.05
Comments Comparisons of the means were accomplished via student's t-test with Bonferroni correction for multiple comparisons.
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups
Hide Description Mean CVI from incision to propofol off reported as the mean CVI +/- 95% confidence interval for the two groups
Time Frame Maintenance Anesthesia
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil 2ng/ml Remifentanil 8 ng/ml
Hide Arm/Group Description:
The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
Overall Number of Participants Analyzed 33 38
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.73
(1.56 to 1.9)
1.38
(1.31 to 1.45)
Time Frame 1 year
Adverse Event Reporting Description Response to mediations for laryngoscopy in the operating room
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description Rocuronium dose 0 mg/kg Rocuronium dose 0.2 mg/kg Rocuronium dose 0.4 mg/kg Rocuronium dose 0.6 mg/kg
All-Cause Mortality
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/17 (0.00%) 
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.
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
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01450813     History of Changes
Other Study ID Numbers: COVMOPR0176
First Submitted: September 22, 2011
First Posted: October 12, 2011
Results First Submitted: March 10, 2016
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017