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)
- Conditions
- Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery
- Interventions
- Other: No neuromuscular blockade (NMB)-reversal agent usedDrug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice
- Registration Number
- NCT01213264
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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). 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 659
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spontaneous NMB reversal No neuromuscular blockade (NMB)-reversal agent used Participants whose reversal from NMB is spontaneous (no reversal agent used) NMB reversal with other agents Other NMB-Reversal Agents Used in Routine Anesthesiology Practice Participants who are administered any other agent (other than sugammadex) for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines NMB reversal with sugammadex Sugammadex Participants who are administered sugammadex for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines
- Primary Outcome Measures
Name Time Method Type of Surgical Procedure Performed in Study Participants Day of surgery (Day 1) The type of surgical procedure performed in each study participant was recorded.
Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation 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 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 NMB-reversal Agent Administered to Study Participants 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.
- Secondary Outcome Measures
Name Time Method Time From NMB-reversal Agent Administration to Recovery Room Dismissal 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.
Time From NMB-reversal Agent Administration to Operating Room Dismissal 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.