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

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Rocuronium; Drug: Succinylcholine; Drug: Cisatracurium; Drug: Mivacurium; Device: Objective neuromuscular monitoring (acceleromyography); Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT02914119
• Lead Sponsor: Jakob Louis Thomsen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Study Start: 2016-10-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Results First Submitted: 2019-05-27
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-03
• Last Update Submitted: 2019-08-03
• Results First Posted: 2019-09-12
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30430

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eligible patients	Rocuronium	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.
Eligible patients	Objective neuromuscular monitoring (acceleromyography)	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.
Eligible patients	Neostigmine	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.
Eligible patients	Succinylcholine	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.
Eligible patients	Cisatracurium	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.
Eligible patients	Mivacurium	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.
Eligible patients	Sugammadex	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.

Primary Outcome Measures

Name	Time	Method
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
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 Outcome Measures

Name	Time	Method
Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA	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)	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)	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	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	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	in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark