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CompletedNCT02914119Updated Sep 12, 2019Results posted

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

An observational study in Neuromuscular Blockade, sponsored by Jakob Louis Thomsen. Completed at 1 site in Denmark. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Jakob Louis Thomsen · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
30,430
Ages
15 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Neuromuscular Blockade

Keywords

  • Residual nerve blockade
  • Neuromuscular monitoring
  • Residual curarization
  • Neuromuscular blocking agents
03

In context

Lead sponsor

This is the only study on the registry with Jakob Louis Thomsen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who received general anaesthesia with neuromuscular blockade

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

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
30,430 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • DrugRocuronium
  • DrugSuccinylcholine
  • DrugCisatracurium
  • DrugMivacurium
  • DeviceObjective neuromuscular monitoring (acceleromyography)
  • DrugSugammadex
  • DrugNeostigmine
06

What researchers measure

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

07

Results

Posted Sep 12, 2019

Participant flow

Participant flow — Overall Study
MilestoneEligible Patients
Started30430
Completed30430
Not completed0

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)
ParticipantsEligible Patients
Monitoring applied14463
Monitoring not applied2062
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)
ParticipantsEligible Patients
Monitoring applied4224
Monitoring not applied9681
SecondaryLast 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
Reported as:
Median · Train-of-four ratio
Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
Train-of-four ratioEligible Patients
Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA0.97 (0.90 to 1.06)
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
ParticipantsEligible Patients
Yes145
No12945
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
ParticipantsEligible Patients
Yes8570
No7955
SecondaryTime 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
Reported as:
Median · Minutes
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
MinutesEligible Patients
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, Respectively97 (63 to 157)
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA
ParticipantsEligible Patients
Desaturation1753
No desaturation14230
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA
ParticipantsEligible Patients
Desaturation295
No desaturation15688

Adverse events

Collected over Averse events data were not collected for the study because it was a retrospective database study. Adverse events were collected and reported by individual institutions according to local procedure.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Eligible Patients———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Eligible Patients
Mean57 ± 20
Sex: Female, Male
Sex: Female, Male(Participants)Eligible Patients
Female16920
Male13510
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Eligible Patients
08

Study locations

1 site
  • Herlev Hospital
    Herlev, Denmark
09

References and documents

Study documents

  • Study protocol · Aug 3, 2019
  • Statistical analysis plan · Aug 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Sharing of data not included in the permissions granted by authorities stated below

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02914119
Lead sponsor
Jakob Louis Thomsen
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Jakob Louis Thomsen (MD, Herlev Hospital) — Sponsor-investigator
First posted
Sep 26, 2016
Start date
Oct 1, 2016
Primary completion
Jun 1, 2017
Completion
Jun 1, 2017
Results posted
Sep 12, 2019
Last update
Sep 12, 2019

Study contacts

Jakob L Thomsen, MD
principal investigator · Sponsor principal investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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