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

Neuromuscular Blockade Clinical Trial

Official title:

Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals - a Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914119
• Other study ID #: JLT-NM4
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: June 1, 2017

Study information

• Verified date: August 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30430
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Rocuronium

• Succinylcholine

• Cisatracurium

• Mivacurium

Device:
• Objective neuromuscular monitoring (acceleromyography)

Drug:
• Sugammadex

• Neostigmine

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Jakob Louis Thomsen	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)		in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Primary	Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)		in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Secondary	Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA	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.	in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Secondary	Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)		in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Secondary	Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)		in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Secondary	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		in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
Secondary	Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA		in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours
Secondary	Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA		in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours