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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02914119

Enrollment

30430

Registered

2016-09-26

Start date

2016-10-01

Completion date

2017-06-01

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents

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).

Interventions

DRUGRocuronium

DRUGSuccinylcholine

DRUGCisatracurium

DRUGMivacurium

DEVICEObjective neuromuscular monitoring (acceleromyography)

DRUGSugammadex

DRUGNeostigmine

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	—
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 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	—
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 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	—

Countries

Denmark

Participant flow

Pre-assignment details

Estimated number of included cases

Participants by arm

Arm	Count
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. Rocuronium Succinylcholine Cisatracurium Mivacurium Objective neuromuscular monitoring (acceleromyography) Sugammadex Neostigmine	30,430
Total	30,430

Arm

Count

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. Rocuronium Succinylcholine Cisatracurium Mivacurium Objective neuromuscular monitoring (acceleromyography) Sugammadex Neostigmine

30,430

Total

30,430

Baseline characteristics

Characteristic	Eligible Patients	—
Age, Continuous	57 years STANDARD_DEVIATION 20	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	16920 Participants	—
Sex: Female, Male Male	13510 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

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

Population: Patients receiving succinylcholine only

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Eligible Patients	Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)	Monitoring applied	4224 Participants
Eligible Patients	Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)	Monitoring not applied	9681 Participants

Primary

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

Population: Patients receiving non-depolarizing neuromuscular blocking agent

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Eligible Patients	Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)	Monitoring applied	14463 Participants
Eligible Patients	Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)	Monitoring not applied	2062 Participants

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.

Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours