Trial Outcomes & Findings for Observational Study to Evaluate the Current Neuromuscular Monitoring Practice Used After Different Types of Surgery, for Which Neuromuscular Blocking Agents Were Used, With or Without Blocking Reversal (P06556) (NCT NCT01213264)
NCT ID: NCT01213264
Last Updated: 2015-03-17
Results Overview
Neuromuscular function assessment was performed according to routine anesthesiology practice. This typically involves application of repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve and assessment of twitch response at the adductor pollicis muscle. The TOF-ratio, expressed as a decimal from 0.0 up to 1.0, is the ratio of the magnitude of the fourth twitch (T4) to that of the first twitch (T1). The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. The TOF-ratio was measured at the time of post-surgical extubation. TOF-ratio at time of extubation was to be recorded for each participant, if available, irrespective of the criteria used to make the decision to extubate the participant. TOF-ratio \<0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.
COMPLETED
659 participants
At extubation (approximately <1 to 125 minutes after end of surgery)
2015-03-17
Participant Flow
Participant milestones
| Measure |
Spontaneous Reversal
Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used)
|
Sugammadex
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Overall Study
STARTED
|
155
|
177
|
327
|
|
Overall Study
COMPLETED
|
153
|
175
|
321
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
6
|
Reasons for withdrawal
| Measure |
Spontaneous Reversal
Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used)
|
Sugammadex
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
6
|
Baseline Characteristics
Observational Study to Evaluate the Current Neuromuscular Monitoring Practice Used After Different Types of Surgery, for Which Neuromuscular Blocking Agents Were Used, With or Without Blocking Reversal (P06556)
Baseline characteristics by cohort
| Measure |
Spontaneous Reversal
n=155 Participants
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
n=177 Participants
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
n=327 Participants
Participants administered any other agent (other than sugammadex) for NMB reversal
|
Total
n=659 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
425 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
234 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At extubation (approximately <1 to 125 minutes after end of surgery)Population: Evaluable participants with TOF-ratio measurement at time of extubation
Neuromuscular function assessment was performed according to routine anesthesiology practice. This typically involves application of repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve and assessment of twitch response at the adductor pollicis muscle. The TOF-ratio, expressed as a decimal from 0.0 up to 1.0, is the ratio of the magnitude of the fourth twitch (T4) to that of the first twitch (T1). The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. The TOF-ratio was measured at the time of post-surgical extubation. TOF-ratio at time of extubation was to be recorded for each participant, if available, irrespective of the criteria used to make the decision to extubate the participant. TOF-ratio \<0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.
Outcome measures
| Measure |
Spontaneous Reversal
n=137 Participants
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
n=175 Participants
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
n=318 Participants
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation
|
55 participants
|
17 participants
|
95 participants
|
PRIMARY outcome
Timeframe: From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)Population: Evaluable participants with TOF-ratio measurement at time of extubation and available procedure duration data. Three sugammadex participants with duration from end of surgery to extubation \>1 hour were excluded from analysis; delay of extubation was considered due to factors unrelated to administration of sugammadex.
This measure is the duration from the last surgical wound stitch to the post-surgical extubation of the participant. The time of extubation was to be recorded for each participant, irrespective of the criteria used to make the decision to extubate the participant. Data are presented by TOF-ratio \<0.9 and ≥0.9 at extubation. The TOF-ratio is a measure of neuromuscular function ranging from 0.0 to 1.0. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. TOF-ratio \<0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.
Outcome measures
| Measure |
Spontaneous Reversal
n=137 Participants
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
n=172 Participants
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
n=318 Participants
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Time From End of Surgery (End of Last Stitch) to Extubation
TOF-ratio <0.9 at extubation (N=55, 17, 95)
|
12.80 minutes
Standard Deviation 11.54
|
8.82 minutes
Standard Deviation 5.16
|
11.76 minutes
Standard Deviation 7.14
|
|
Time From End of Surgery (End of Last Stitch) to Extubation
TOF-ratio ≥0.9 at extubation (N=82, 155, 223)
|
9.73 minutes
Standard Deviation 7.96
|
10.01 minutes
Standard Deviation 7.28
|
12.20 minutes
Standard Deviation 6.97
|
PRIMARY outcome
Timeframe: Day of surgery (Day 1)Population: All study participants who received a neuromuscular blocking agent (NMBA) or NMB-reversal agent
The type of surgical procedure performed in each study participant was recorded.
Outcome measures
| Measure |
Spontaneous Reversal
n=659 Participants
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Type of Surgical Procedure Performed in Study Participants
cholecystectomy
|
129 participants
|
—
|
—
|
|
Type of Surgical Procedure Performed in Study Participants
nasal septal operation
|
47 participants
|
—
|
—
|
|
Type of Surgical Procedure Performed in Study Participants
thyroidectomy
|
36 participants
|
—
|
—
|
|
Type of Surgical Procedure Performed in Study Participants
intervertebral disc operation
|
34 participants
|
—
|
—
|
|
Type of Surgical Procedure Performed in Study Participants
hysterectomy
|
28 participants
|
—
|
—
|
|
Type of Surgical Procedure Performed in Study Participants
other surgical procedure
|
385 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)Population: All study participants who received an NMBA or NMB-reversal agent
For all participants who received an NMB-reversal agent, the specific agent administered was recorded.
Outcome measures
| Measure |
Spontaneous Reversal
n=659 Participants
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Type of NMB-reversal Agent Administered to Study Participants
neostigmine
|
327 participants
|
—
|
—
|
|
Type of NMB-reversal Agent Administered to Study Participants
sugammadex
|
177 participants
|
—
|
—
|
|
Type of NMB-reversal Agent Administered to Study Participants
NMB-reversal agent not administered
|
155 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-surgical period (up to approximately 24 hours post-surgery)Population: Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.
This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Operating Room. The time of dismissal from the Operating Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.
Outcome measures
| Measure |
Spontaneous Reversal
n=124 Participants
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
n=194 Participants
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Time From NMB-reversal Agent Administration to Operating Room Dismissal
|
15.90 minutes
Standard Deviation 14.96
|
40.46 minutes
Standard Deviation 109.9
|
—
|
SECONDARY outcome
Timeframe: Post-surgical and recovery period (up to approximately 170 hours post-surgery)Population: Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.
This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Recovery Room. The time of dismissal from the Recovery Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.
Outcome measures
| Measure |
Spontaneous Reversal
n=130 Participants
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
n=199 Participants
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Time From NMB-reversal Agent Administration to Recovery Room Dismissal
|
630.5 minutes
Standard Deviation 1070
|
619.2 minutes
Standard Deviation 1348
|
—
|
Adverse Events
Spontaneous Reversal
Sugammadex
Other Reversal Agents
Serious adverse events
| Measure |
Spontaneous Reversal
n=155 participants at risk
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
n=177 participants at risk
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
n=327 participants at risk
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Cardiac disorders
bradyarrythmia
|
0.00%
0/155
|
0.56%
1/177 • Number of events 1
|
0.00%
0/327
|
|
Immune system disorders
Type I hypersensitivity
|
0.00%
0/155
|
0.56%
1/177 • Number of events 1
|
0.00%
0/327
|
|
Infections and infestations
pneumonia
|
0.00%
0/155
|
0.00%
0/177
|
0.31%
1/327 • Number of events 1
|
|
Investigations
airway peak pressure increased
|
0.00%
0/155
|
0.56%
1/177 • Number of events 1
|
0.00%
0/327
|
|
Investigations
oxygen saturation decreased
|
0.00%
0/155
|
0.56%
1/177 • Number of events 1
|
0.00%
0/327
|
|
Renal and urinary disorders
urinary incontinence
|
0.00%
0/155
|
0.56%
1/177 • Number of events 1
|
0.00%
0/327
|
|
Respiratory, thoracic and mediastinal disorders
laryngospasm
|
0.00%
0/155
|
0.00%
0/177
|
0.31%
1/327 • Number of events 1
|
|
Vascular disorders
flushing
|
0.00%
0/155
|
0.56%
1/177 • Number of events 1
|
0.00%
0/327
|
|
Vascular disorders
shock haemorrhagic
|
1.3%
2/155 • Number of events 3
|
0.00%
0/177
|
0.00%
0/327
|
|
Vascular disorders
venous thrombosis
|
0.00%
0/155
|
0.56%
1/177 • Number of events 1
|
0.00%
0/327
|
Other adverse events
| Measure |
Spontaneous Reversal
n=155 participants at risk
Participants whose reversal from NMB was spontaneous (no reversal agent used)
|
Sugammadex
n=177 participants at risk
Participants administered sugammadex for NMB reversal
|
Other Reversal Agents
n=327 participants at risk
Participants administered any other agent (other than sugammadex) for NMB reversal
|
|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
2.6%
4/155 • Number of events 5
|
5.6%
10/177 • Number of events 10
|
3.1%
10/327 • Number of events 10
|
|
Injury, poisoning and procedural complications
procedural pain
|
9.7%
15/155 • Number of events 15
|
7.9%
14/177 • Number of events 14
|
4.3%
14/327 • Number of events 14
|
|
Vascular disorders
hypotension
|
1.9%
3/155 • Number of events 4
|
0.56%
1/177 • Number of events 1
|
5.5%
18/327 • Number of events 20
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Results from Investigator's site will initially only be published/presented with results from the other sites, unless permission is obtained to publish separate results. Investigator will not publish interim results. Sponsor must be able to review all proposed study results communications 45 days prior to submission for publication/presentation. If parties disagree concerning appropriateness of proposed content, Investigator will meet with Sponsor's representatives to discuss/resolve any issues.
- Publication restrictions are in place
Restriction type: OTHER