Trial Outcomes & Findings for Best Management of Muscle Relaxation- Objective Monitoring (NCT NCT03958201)
NCT ID: NCT03958201
Last Updated: 2022-11-02
Results Overview
Train-of-four ratio \<0.9 as measured by electromyography or \<1.0 measured by acceleromyography
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
Within two minutes of extubation
Results posted on
2022-11-02
Participant Flow
200 subjects were enrolled in the study. However, only 189 subjects started and completed the study cute due to surgeries being cancelled, no Rocuronium given, missing data, or monitor malfunction.
Participant milestones
| Measure |
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium
Subjects undergoing elective surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (objectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.
|
|---|---|
|
Overall Study
STARTED
|
189
|
|
Overall Study
COMPLETED
|
189
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Best Management of Muscle Relaxation- Objective Monitoring
Baseline characteristics by cohort
| Measure |
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium
n=189 Participants
Subjects undergoing elective surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (objectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
162 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
189 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Within two minutes of extubationTrain-of-four ratio \<0.9 as measured by electromyography or \<1.0 measured by acceleromyography
Outcome measures
| Measure |
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium
n=189 Participants
Subjects undergoing elective surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (objectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.
|
|---|---|
|
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation
|
0 Participants
|
SECONDARY outcome
Timeframe: Within two minutes of extubationTrain-of-four ratio \<0.7 as measured by electromyography
Outcome measures
| Measure |
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium
n=189 Participants
Subjects undergoing elective surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (objectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.
|
|---|---|
|
Incidence of Severe Postoperative Residual Neuromuscular Blockade at Time of Extubation
|
0 Participants
|
Adverse Events
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium
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