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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01213264
First received: September 9, 2010
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 Intervention
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 Type: Observational
Study Design: 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)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    For all participants who received an NMB-reversal agent, the specific agent administered was recorded.


Secondary Outcome Measures:
  • Time From NMB-reversal Agent Administration to Operating Room Dismissal [ Time Frame: Post-surgical period (up to approximately 24 hours post-surgery) ] [ Designated as safety issue: No ]
    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.

  • Time From NMB-reversal Agent Administration to Recovery Room Dismissal [ Time Frame: Post-surgical and recovery period (up to approximately 170 hours post-surgery) ] [ Designated as safety issue: No ]
    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.


Enrollment: 659
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01213264     History of Changes
Other Study ID Numbers: P06556
Study First Received: September 9, 2010
Results First Received: April 4, 2013
Last Updated: March 18, 2014
Health Authority: Hungary: Medical Research Council Scientific and Research Ethics Committee

Keywords provided by Merck Sharp & Dohme Corp.:
neuromuscular blockade, NMBA, sugammadex, Bridion, TOF,

Additional relevant MeSH terms:
Anesthetics
Neuromuscular Blocking Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014