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)

• ClinicalTrials.gov Identifier: NCT01213264
• Recruitment Status: Completed
• First Posted: October 1, 2010
• Results First Posted: May 27, 2013
• Last Update Posted: March 17, 2015
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

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.

Condition or disease	Intervention/treatment
Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery	Other: No neuromuscular blockade (NMB)-reversal agent used; Drug: Sugammadex; Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice

Study Design

• Study Type: Observational
• Actual Enrollment: 659 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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)
• Study Start Date: September 2010
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Groups and Cohorts

Group/Cohort	Intervention/treatment
Spontaneous NMB reversal; Participants whose reversal from NMB is spontaneous (no reversal agent used)	Other: No neuromuscular blockade (NMB)-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	Drug: Sugammadex; 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: Bridion; SCH 900616
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	Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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.

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01213264
• Other Study ID Numbers: P06556
• First Posted: October 1, 2010
• Results First Posted: May 27, 2013
• Last Update Posted: March 17, 2015
• Last Verified: February 2015

Keywords provided by Merck Sharp & Dohme LLC:

neuromuscular blockade, NMBA, sugammadex, Bridion, TOF,

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs