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Trial Outcomes & Findings for The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy (NCT NCT01450813)

NCT ID: NCT01450813

Last Updated: 2017-05-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention

Results posted on

2017-05-12

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
20
20
20
20
Overall Study
COMPLETED
19
19
20
17
Overall Study
NOT COMPLETED
1
1
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
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
Overall Study
Physician Decision
1
1
0
3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1
n=19 Participants
Rocuronium dose 0 mg/kg prior to laryngoscopy
Group 2
n=19 Participants
Rocuronium dose 0.2 mg/kg prior to laryngoscopy
Group 3
n=20 Participants
Rocuronium dose 0.4 mg/kg prior to laryngoscopy
Group 4
n=17 Participants
Rocuronium dose 0.6 mg/kg prior to laryngoscopy
Total
n=75 Participants
Total of all reporting groups
Age, Continuous
35.9 years
STANDARD_DEVIATION 12.3 • n=5 Participants
38.6 years
STANDARD_DEVIATION 14.6 • n=7 Participants
39.4 years
STANDARD_DEVIATION 12.7 • n=5 Participants
32.9 years
STANDARD_DEVIATION 6.4 • n=4 Participants
37.9 years
STANDARD_DEVIATION 11.34 • n=21 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
8 Participants
n=7 Participants
8 Participants
n=5 Participants
9 Participants
n=4 Participants
34 Participants
n=21 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
11 Participants
n=7 Participants
12 Participants
n=5 Participants
8 Participants
n=4 Participants
41 Participants
n=21 Participants

PRIMARY outcome

Timeframe: Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention

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.

Outcome measures

Outcome measures
Measure
Group 1
n=20 Participants
Rocuronium 0mg/kg
Group 2
n=19 Participants
Rocuronium 0.2mg/kg
Group 3
n=20 Participants
Rocuronium 0.4mg/kg
Group 4
n=16 Participants
Rocuronium 0.6mg/kg
The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups
2.40 units on a scale
Interval 2.15 to 2.64
1.39 units on a scale
Interval 0.95 to 1.83
0.48 units on a scale
Interval 0.24 to 0.72
0.17 units on a scale
Interval -0.04 to 0.38

SECONDARY outcome

Timeframe: Maintenance Anesthesia

Mean CVI from incision to propofol off reported as the mean CVI +/- 95% confidence interval for the two groups

Outcome measures

Outcome measures
Measure
Group 1
n=33 Participants
Rocuronium 0mg/kg
Group 2
n=38 Participants
Rocuronium 0.2mg/kg
Group 3
Rocuronium 0.4mg/kg
Group 4
Rocuronium 0.6mg/kg
The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups
1.73 units on a scale
Interval 1.56 to 1.9
1.38 units on a scale
Interval 1.31 to 1.45
—
—

Adverse Events

Group 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 3

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 4

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Donald Mathews, M.D.

Fletcher Allen Health Care at The University of Vermont

Phone: (802) 847-2415

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place