Clinical trial NCT02914119: Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals
Official title: Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals - a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: Residual nerve blockade
Neuromuscular monitoring
Residual curarization
Neuromuscular blocking agents
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-09-26
Enrollment: 30430
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received general anaesthesia with neuromuscular blockade

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).


Eligibility 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

Primary outcomes:
measure: Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)
timeFrame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
measure: Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)
timeFrame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Secondary outcomes:
measure: Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
timeFrame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
measure: Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
timeFrame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
measure: Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
timeFrame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
measure: 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
timeFrame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
measure: Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA
timeFrame: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours
measure: Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA
timeFrame: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Sponsor principal investigator
name: Jakob L Thomsen, MD
role: PRINCIPAL_INVESTIGATOR
References: