- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213264
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)
Observational Project on the Current Neuromuscular Monitoring Practice (Including Extubation Practice) Via TOF-ratio (Train-of-four) Measurements in Different Types of Surgery After Administration of Neuromuscular Blocking Agents With or Without Reversal (Protocol No. P06556)
Study Overview
Status
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
All of the criteria below must be met for a participant to be eligible for study participation.
The prospective participant:
- Is an adult, 18 to 65 years-of-age;
- Is to undergo surgery requiring general anesthesia with non-depolarizing NMBA administration, with or without NMB reversal;
- Meets the inclusion criteria listed on the NMBA label in each country;
- Is willing to participate and sign an informed consent form (ICF).
Exclusion Criteria
Exclusion from the study will be determined by the treating physician. In addition the criteria below should be considered in determining those participants who should be excluded from the study.
The prospective participant:
- Is pregnant or breast feeding;
- Has a neuromuscular disorder;
- Has severe hepatic impairment;
- Has severe renal impairment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Spontaneous NMB reversal
Participants whose reversal from NMB is spontaneous (no reversal agent used)
|
Participants whose reversal from NMB is spontaneous (no reversal agent used)
|
NMB reversal with sugammadex
Participants who are administered sugammadex for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines
|
Participants receive NMB-reversal agents at the discretion of the treating physician per label according to local guidelines, in accordance with routine anesthesiology practice. As this is a prospective observational study designed to collect data as part of routine clinical practice, the protocol does not assign which reversal agents, if any, are to be used. This intervention is associated with a cohort that is intended to include participants who receive the NMB-reversal agent sugammadex, administered according to the local clinical practice and drug product labeling.
Other Names:
|
NMB reversal with other agents
Participants who are administered any other agent (other than sugammadex) for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines
|
Participants receive NMB-reversal agents at the discretion of the treating physician per label according to local guidelines, in accordance with routine anesthesiology practice. As this is a prospective observational study designed to collect data as part of routine clinical practice, the protocol does not assign which reversal agents, if any, are to be used. This intervention is associated with a cohort that is intended to include participants who receive any NMB-reversal agent other than sugammadex, and represents multiple drugs whose use and administration may vary according to local clinical practice, product availability and product labeling. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation
Time Frame: At extubation (approximately <1 to 125 minutes after end of surgery)
|
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.
|
At extubation (approximately <1 to 125 minutes after end of surgery)
|
Time From End of Surgery (End of Last Stitch) to Extubation
Time Frame: From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)
|
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. |
From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)
|
Type of Surgical Procedure Performed in Study Participants
Time Frame: Day of surgery (Day 1)
|
The type of surgical procedure performed in each study participant was recorded.
|
Day of surgery (Day 1)
|
Type of NMB-reversal Agent Administered to Study Participants
Time Frame: At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)
|
For all participants who received an NMB-reversal agent, the specific agent administered was recorded.
|
At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From NMB-reversal Agent Administration to Operating Room Dismissal
Time Frame: Post-surgical period (up to approximately 24 hours post-surgery)
|
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.
|
Post-surgical period (up to approximately 24 hours post-surgery)
|
Time From NMB-reversal Agent Administration to Recovery Room Dismissal
Time Frame: Post-surgical and recovery period (up to approximately 170 hours post-surgery)
|
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.
|
Post-surgical and recovery period (up to approximately 170 hours post-surgery)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P06556
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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