Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals

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ClinicalTrials.gov Identifier: NCT02914119

Recruitment Status : Completed

First Posted : September 26, 2016

Results First Posted : September 12, 2019

Last Update Posted : September 12, 2019

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Jakob Louis Thomsen, Herlev Hospital

Study Description

Brief Summary:

Aim: To explore

the frequency of use of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia
the incidence of residual neuromuscular blockade, and
the timing of reversal of the neuromuscular blockade at the end of anaesthesia.

We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia Information Management System (AIMS).

Condition or disease	Intervention/treatment
Neuromuscular Blockade	Drug: Rocuronium Drug: Succinylcholine Drug: Cisatracurium Drug: Mivacurium Device: Objective neuromuscular monitoring (acceleromyography) Drug: Sugammadex Drug: Neostigmine

Study Design

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Study Type :	Observational [Patient Registry]
Actual Enrollment :	30430 participants
Observational Model:	Other
Time Perspective:	Cross-Sectional
Target Follow-Up Duration:	1 Day
Official Title:	Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals - a Cross-sectional Study
Actual Study Start Date :	October 1, 2016
Actual Primary Completion Date :	June 1, 2017
Actual Study Completion Date :	June 1, 2017

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Eligible patients Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.	Drug: Rocuronium Drug: Succinylcholine Drug: Cisatracurium Drug: Mivacurium Device: Objective neuromuscular monitoring (acceleromyography) Drug: Sugammadex Drug: Neostigmine

Outcome Measures

Primary Outcome Measures :

Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no) [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours ]
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no) [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours ]

Secondary Outcome Measures :

Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours ]
The train-of-four (TOF) ratio is the ratio between the last and first measurements after four stimuli of the ulnar nerve at 2 Hz. The ratio should be at least 0.9 before tracheal extubation.
Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no) [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours ]
Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no) [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours ]
Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes ]
Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA [ Time Frame: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours ]
Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA [ Time Frame: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:	15 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who received general anaesthesia with neuromuscular blockade

Criteria

Inclusion Criteria:

Patients who received general anaesthesia with neuromuscular blockade in one of the 7 hospitals providing data for the study in the last 18 months up until the time of data collection

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914119

Locations

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Denmark
Herlev Hospital
Herlev, Denmark

Sponsors and Collaborators

Jakob Louis Thomsen

Merck Sharp & Dohme Corp.

Investigators

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Principal Investigator:	Jakob L Thomsen, MD	Sponsor principal investigator

Study Documents (Full-Text)

Documents provided by Jakob Louis Thomsen, Herlev Hospital:

Study Protocol [PDF] August 3, 2019

Statistical Analysis Plan [PDF] August 3, 2019

More Information

Additional Information:

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Responsible Party:	Jakob Louis Thomsen, MD, Herlev Hospital
ClinicalTrials.gov Identifier:	NCT02914119
Other Study ID Numbers:	JLT-NM4
First Posted:	September 26, 2016 Key Record Dates
Results First Posted:	September 12, 2019
Last Update Posted:	September 12, 2019
Last Verified:	August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Sharing of data not included in the permissions granted by authorities stated below

Keywords provided by Jakob Louis Thomsen, Herlev Hospital:


Residual nerve blockade Neuromuscular monitoring Residual curarization Neuromuscular blocking agents

Additional relevant MeSH terms:

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Rocuronium Mivacurium Cisatracurium Succinylcholine Neostigmine Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Parasympathomimetics Autonomic Agents Neuromuscular Depolarizing Agents

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