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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02914119
Other study ID # JLT-NM4
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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