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)

NCT01213264 | Completed Results

• 1 other identifier: P06556
• Study Type: observational
• Target: 659
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery

Keywords

neuromuscular blockade, NMBA, sugammadex, Bridion, TOF,

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

Secondary Outcomes (2)

• Time From NMB-reversal Agent Administration to Operating Room Dismissal

  Post-surgical period (up to approximately 24 hours post-surgery)

• Time From NMB-reversal Agent Administration to Recovery Room Dismissal

  Post-surgical and recovery period (up to approximately 170 hours post-surgery)

Study Arms (3)

Spontaneous NMB reversal

Participants whose reversal from NMB is spontaneous (no reversal agent used)

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

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

Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice

Interventions

No neuromuscular blockade (NMB)-reversal agent used OTHER

Participants whose reversal from NMB is spontaneous (no reversal agent used)

Spontaneous NMB reversal

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.

Also known as: Bridion, SCH 900616

NMB reversal with sugammadex

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.

NMB reversal with other agents

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• Is willing to participate and sign an informed consent form (ICF).

You may not qualify if:

• The prospective participant:
• Is pregnant or breast feeding;
• Has a neuromuscular disorder;
• Has severe hepatic impairment;
• Has severe renal impairment.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Tetralogy of Fallot

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: October 1, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 17, 2015
• Results First Posted: May 27, 2013

Record last verified: 2015-02