Trial Outcomes & Findings for Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex (NCT NCT03543826)
NCT ID: NCT03543826
Last Updated: 2022-11-09
Results Overview
Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
Within five minutes of arrival to the post-anesthesia care unit.
Results posted on
2022-11-09
Participant Flow
201 subjects were consented to the study. However, 163 subjects completed the study and were included in the primary per-protocol analysis.
Participant milestones
| Measure |
Subjects Undergoing Orthopedic or Abdominal Surgery
Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.
|
|---|---|
|
Overall Study
STARTED
|
163
|
|
Overall Study
COMPLETED
|
163
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex
Baseline characteristics by cohort
| Measure |
Subjects Undergoing Orthopedic or Abdominal Surgery
n=163 Participants
Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively 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=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
163 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within five minutes of arrival to the post-anesthesia care unit.Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.
Outcome measures
| Measure |
Subjects Undergoing Orthopedic or Abdominal Surgery
n=163 Participants
Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively 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 Arrival to the Post-anesthesia Care Unit.
|
5 Participants
|
SECONDARY outcome
Timeframe: Within five minutes of arrival to the post-anesthesia care unit.Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography.
Outcome measures
| Measure |
Subjects Undergoing Orthopedic or Abdominal Surgery
n=163 Participants
Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.
|
|---|---|
|
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.
|
2 Participants
|
SECONDARY outcome
Timeframe: Within two minutes of time of extubation.Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.
Outcome measures
| Measure |
Subjects Undergoing Orthopedic or Abdominal Surgery
n=161 Participants
Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively 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 Tracheal Extubation.
|
14 Participants
|
SECONDARY outcome
Timeframe: Within two minutes of time of extubation.Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography.
Outcome measures
| Measure |
Subjects Undergoing Orthopedic or Abdominal Surgery
n=161 Participants
Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.
|
|---|---|
|
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation
|
1 Participants
|
Adverse Events
Subjects Undergoing Orthopedic or Abdominal Surgery
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