Trial Outcomes & Findings for The Effect of Pretreatment With Roc on Succinylcholine Myalgias (NCT NCT04581395)
NCT ID: NCT04581395
Last Updated: 2024-08-21
Results Overview
The data are reported as pain (scores 1-4) vs. no pain (score 0).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
3 hours post succinylcholine administration
Results posted on
2024-08-21
Participant Flow
Participant milestones
| Measure |
Not Pretreated With Rocuronium
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
96
|
96
|
98
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
2
|
Reasons for withdrawal
| Measure |
Not Pretreated With Rocuronium
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Not Pretreated
n=96 Participants
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated 1 Minute Before Succinylcholine Administration
n=96 Participants
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated 2 Minutes Before Succinylcholine Administratjion
n=98 Participants
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 15 • n=96 Participants
|
62 years
STANDARD_DEVIATION 14 • n=96 Participants
|
59 years
STANDARD_DEVIATION 16 • n=98 Participants
|
60 years
STANDARD_DEVIATION 15 • n=290 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=96 Participants
|
55 Participants
n=96 Participants
|
48 Participants
n=98 Participants
|
153 Participants
n=290 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=96 Participants
|
41 Participants
n=96 Participants
|
50 Participants
n=98 Participants
|
137 Participants
n=290 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 3 hours post succinylcholine administrationThe data are reported as pain (scores 1-4) vs. no pain (score 0).
Outcome measures
| Measure |
Not Pretreated With Rocuronium
n=96 Participants
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
n=96 Participants
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
n=98 Participants
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
|---|---|---|---|
|
Myalgias Perceived at 3 Hours
Patients with no pain 3 hours post succinylcholine
|
81 Participants
|
83 Participants
|
83 Participants
|
|
Myalgias Perceived at 3 Hours
Patients who described having pain 3 hours post succinylcholine
|
15 Participants
|
13 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 24 hours post succinylcholine administrationThe presence of myalgias referencing a severity scale from 0 (no muscle pain), 1 (mild muscle pain), 2(moderate muscle pain), 3 (Moderate muscle pain) and 4 (Severe muscle pain). The data are reported as pain (scores 1-4) vs. no pain (score 0)
Outcome measures
| Measure |
Not Pretreated With Rocuronium
n=96 Participants
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
n=96 Participants
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
n=98 Participants
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
|---|---|---|---|
|
Myalgias at 24 Hours Post Succinylcholine Administration.
patients experiencing no pain 24 hours post succinylcholine administrations
|
64 Participants
|
78 Participants
|
80 Participants
|
|
Myalgias at 24 Hours Post Succinylcholine Administration.
Patients experiencing pain at 24 hours post succinylcholine administrations
|
32 Participants
|
18 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 3 hours post succinylcholine administration0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.
Outcome measures
| Measure |
Not Pretreated With Rocuronium
n=96 Participants
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
n=96 Participants
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
n=98 Participants
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
|---|---|---|---|
|
Pain Scores
Pain score =0
|
81 Participants
|
83 Participants
|
83 Participants
|
|
Pain Scores
Pain score = 1
|
10 Participants
|
12 Participants
|
12 Participants
|
|
Pain Scores
Pain score = 2
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Pain Scores
Pain score = 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Pain Scores
Pain score = 4
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 24 hours post succinylcholine administration.0=no muscle pain/stiffness, 1=mild muscle pain/stiffness not limiting daily activity, 2=moderate muscle pain/stiffness not limiting daily activity, 3=moderate muscle pain stiffness that limits daily activity, 4=severe muscle pain/stiffness limiting movement and preventing daily activity. Values averaged.
Outcome measures
| Measure |
Not Pretreated With Rocuronium
n=96 Participants
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
n=96 Participants
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
n=98 Participants
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
|---|---|---|---|
|
Pain Scores
24 hour pain scores = 0
|
64 Participants
|
78 Participants
|
80 Participants
|
|
Pain Scores
24 hour pain scores=1
|
20 Participants
|
9 Participants
|
16 Participants
|
|
Pain Scores
24 hour pain score=2
|
7 Participants
|
8 Participants
|
0 Participants
|
|
Pain Scores
24 pain score =3
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Pain Scores
24 pain score=4
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: immediately following succinylcholine administration up to 2 minutesObserved presence or absence of muscle fasciculation following succinylcholine administration in subjects pretreated with rocuronium 1 minute prior to succinylcholine administration or 2 minutes prior to succinylcholine administration compared to the control group not pretreated with rocuronium.
Outcome measures
| Measure |
Not Pretreated With Rocuronium
n=96 Participants
Succinylcholine administration with no Rocuronium pre-treatment
non-pretreated Succinylcholine: no pretreatment
|
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
n=96 Participants
Succinylcholine administration 1 minute following Rocuronium pre-treatment
succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
|
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
n=98 Participants
Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment
succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
|
|---|---|---|---|
|
Number of Participants With Observed Presence of Muscle Fasciculation Following Succinylcholine Administration
|
75 Participants
|
20 Participants
|
13 Participants
|
Adverse Events
Not Pretreated With Rocuronium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion
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
Dr. Leighan Bye, Assistant Professor of Clinical Anesthesia
IU school of Medicine, Department of Anesthesiology
Phone: 317-274-0275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place