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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous NMB reversal | 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 |
| |
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No neuromuscular blockade (NMB)-reversal agent used | Other | Participants whose reversal from NMB is spontaneous (no reversal agent used) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day of surgery (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-surgical period (up to approximately 24 hours post-surgery) |
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Inclusion Criteria
All of the criteria below must be met for a participant to be eligible for study participation.
The prospective participant:
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:
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spontaneous Reversal | Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used) |
| FG001 | Sugammadex | Participants administered sugammadex for NMB reversal |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sugammadex | Drug | 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. |
|
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| Other NMB-Reversal Agents Used in Routine Anesthesiology Practice | Drug | 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. |
|
| Type of NMB-reversal Agent Administered to Study Participants |
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) |
| 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. | Post-surgical and recovery period (up to approximately 170 hours post-surgery) |
| FG002 | Other Reversal Agents | Participants administered any other agent (other than sugammadex) for NMB reversal |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spontaneous Reversal | Participants whose reversal from NMB was spontaneous (no reversal agent used) |
| BG001 | Sugammadex | Participants administered sugammadex for NMB reversal |
| BG002 | Other Reversal Agents | Participants administered any other agent (other than sugammadex) for NMB reversal |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Evaluable participants with TOF-ratio measurement at time of extubation | Posted | Number | participants | At extubation (approximately <1 to 125 minutes after end of surgery) |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | minutes | From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes) |
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| Primary | Type of Surgical Procedure Performed in Study Participants | The type of surgical procedure performed in each study participant was recorded. | All study participants who received a neuromuscular blocking agent (NMBA) or NMB-reversal agent | Posted | Number | participants | Day of surgery (Day 1) |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | minutes | Post-surgical period (up to approximately 24 hours post-surgery) |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | minutes | Post-surgical and recovery period (up to approximately 170 hours post-surgery) |
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| Primary | Type of NMB-reversal Agent Administered to Study Participants | For all participants who received an NMB-reversal agent, the specific agent administered was recorded. | All study participants who received an NMBA or NMB-reversal agent | Posted | Number | participants | At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spontaneous Reversal | Participants whose reversal from NMB was spontaneous (no reversal agent used) | 2 | 155 | 21 | 155 | ||
| EG001 | Sugammadex | Participants administered sugammadex for NMB reversal | 3 | 177 | 23 | 177 | ||
| EG002 | Other Reversal Agents | Participants administered any other agent (other than sugammadex) for NMB reversal | 2 | 327 | 40 | 327 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradyarrythmia | Cardiac disorders | MedDRA (15.1) |
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| Type I hypersensitivity | Immune system disorders | MedDRA (15.1) |
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| pneumonia | Infections and infestations | MedDRA (15.1) |
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| airway peak pressure increased | Investigations | MedDRA (15.1) |
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| oxygen saturation decreased | Investigations | MedDRA (15.1) |
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| urinary incontinence | Renal and urinary disorders | MedDRA (15.1) |
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| laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) |
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| flushing | Vascular disorders | MedDRA (15.1) |
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| shock haemorrhagic | Vascular disorders | MedDRA (15.1) |
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| venous thrombosis | Vascular disorders | MedDRA (15.1) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA (15.1) |
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| procedural pain | Injury, poisoning and procedural complications | MedDRA (15.1) |
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| hypotension | Vascular disorders | MedDRA (15.1) |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D013771 | Tetralogy of Fallot |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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| OG002 | Other Reversal Agents | Participants administered any other agent (other than sugammadex) for NMB reversal |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| cholecystectomy |
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| nasal septal operation |
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| thyroidectomy |
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| intervertebral disc operation |
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| hysterectomy |
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| other surgical procedure |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| neostigmine |
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| sugammadex |
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| NMB-reversal agent not administered |
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