Trial Outcomes & Findings for Intubating Conditions of Neuromuscular Blockade (NCT NCT05620108)
NCT ID: NCT05620108
Last Updated: 2025-10-14
Results Overview
The number of subjects who had optimal intubating conditions (total composite score of 3) will be evaluated by the healthcare providers using a scale that includes 3 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will be used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
Approximately 15 minutes after intubation
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
Intubation at TOFC=1
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation)
Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade
|
Intubation 2 Minutes After Rocuronium Administration
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication
Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
|
Overall Study
COMPLETED
|
84
|
83
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Intubation at TOFC=1
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation)
Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade
|
Intubation 2 Minutes After Rocuronium Administration
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication
Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
2
|
Baseline Characteristics
Intubating Conditions of Neuromuscular Blockade
Baseline characteristics by cohort
| Measure |
Intubation at TOFC=1
n=85 Participants
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation)
Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade
|
Intubation 2 Minutes After Rocuronium Administration
n=85 Participants
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication
Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
85 participants
n=7 Participants
|
170 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 15 minutes after intubationThe number of subjects who had optimal intubating conditions (total composite score of 3) will be evaluated by the healthcare providers using a scale that includes 3 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will be used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions.
Outcome measures
| Measure |
Intubation at TOFC=1
n=84 Participants
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation)
Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade
|
Intubation 2 Minutes After Rocuronium Administration
n=83 Participants
Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication
Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)
|
|---|---|---|
|
Number of Subjects With Optimal Intubating Conditions
|
61 Participants
|
47 Participants
|
Adverse Events
Intubation at TOFC=1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intubation 2 Minutes After Rocuronium Administration
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place