Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of SurgeryNCT01213264
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)
An observational study of Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery, run by Merck Sharp & Dohme LLC.
Trial summary
The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery
- What is being tested?
- No neuromuscular blockade (NMB)-reversal agent used, Sugammadex and Other NMB-Reversal Agents Used in Routine Anesthesiology Practice
- How many people
- 659 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Feb 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-65 years old) who are undergoing different types of surgical procedures (short, intermediate, or long in duration), requiring general anesthesia with a non-depolarizing NMBA, with or without NMB reversal.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: 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)
The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all drugs used during anesthesia) will be done in accordance with routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be monitored according to routine anesthesiology practice by means of acceleromyography. The assignment of the participant to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.
- Being tested
- No neuromuscular blockade (NMB)-reversal agent used, Sugammadex, Other NMB-Reversal Agents Used in Routine Anesthesiology Practice
- Keywords
- neuromuscular blockade, NMBA, sugammadex, Bridion, TOF,
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No neuromuscular blockade (NMB)-reversal agent usedOther
Participants whose reversal from NMB is spontaneous (no reversal agent used)
SugammadexDrug
Also called Bridion, SCH 900616
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 NMB-Reversal Agents Used in Routine Anesthesiology PracticeDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous NMB reversal | Participants whose reversal from NMB is spontaneous (no reversal agent used) Receives: Other: No neuromuscular blockade (NMB)-reversal agent used | |
| NMB reversal with sugammadex | Participants who are administered sugammadex for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines Receives: Drug: Sugammadex | |
| 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 Receives: Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at 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.
Measured: At extubation (approximately <1 to 125 minutes after end of surgery)
Time From End of Surgery (End of Last Stitch) to Extubation
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.
Measured: 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
The type of surgical procedure performed in each study participant was recorded.
Measured: Day of surgery (Day 1)
Type of NMB-reversal Agent Administered to Study Participants
For all participants who received an NMB-reversal agent, the specific agent administered was recorded.
Measured: At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)
Secondary outcomes (2)
Time From NMB-reversal Agent Administration to Operating Room Dismissal
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.
Measured: Post-surgical period (up to approximately 24 hours post-surgery)
Time From NMB-reversal Agent Administration to Recovery Room Dismissal
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.
Measured: Post-surgical and recovery period (up to approximately 170 hours post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of SurgeryStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213264
- Sponsor's protocol ID
- P06556
- Status last verified
- Feb 2015
- First submitted
- 9 Sep 2010
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01213264
- Acronym / sponsor ID
- P06556
- Keywords
- neuromuscular blockade, NMBA, sugammadex, Bridion, TOF,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all drugs used during anesthesia) will be done in accordance with routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be monitored according to routine anesthesiology practice by means of acceleromyography. The assignment of the participant to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spontaneous NMB reversal | – | Other: No neuromuscular blockade (NMB)-reversal agent usedParticipants whose reversal from NMB is spontaneous (no reversal agent used) |
| NMB reversal with sugammadex | – | Drug: SugammadexParticipants who are administered sugammadex for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines |
| NMB reversal with other agents | – | Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology PracticeParticipants who are administered any other agent (other than sugammadex) for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-65 years old) who are undergoing different types of surgical procedures (short, intermediate, or long in duration), requiring general anesthesia with a non-depolarizing NMBA, with or without NMB reversal.
Key inclusion criteria (6 listed)
- All of the criteria below must be met for a participant to be eligible for study participation.
- 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).
Key exclusion criteria (6 listed)
- 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.
- Is pregnant or breast feeding;
- Has a neuromuscular disorder;
- Has severe hepatic impairment;
- Has severe renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No neuromuscular blockade (NMB)-reversal agent usedParticipants whose reversal from NMB is spontaneous (no reversal agent used) | Other | Spontaneous NMB reversal |
| SugammadexAlso: Bridion, SCH 900616Participants 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. | Drug | NMB reversal with sugammadex |
| Other NMB-Reversal Agents Used in Routine Anesthesiology PracticeParticipants 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. | Drug | NMB reversal with other agents |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Time From NMB-reversal Agent Administration to Operating Room Dismissal
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.