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Clinical Trials/NCT02914119
NCT02914119
Completed
Not Applicable

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

Jakob Louis Thomsen1 site in 1 country30,430 target enrollmentOctober 1, 2016

Overview

Phase
Not Applicable
Intervention
Rocuronium
Conditions
Neuromuscular Blockade
Sponsor
Jakob Louis Thomsen
Enrollment
30430
Locations
1
Primary Endpoint
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
June 1, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jakob Louis Thomsen
Responsible Party
Sponsor Investigator
Principal Investigator

Jakob Louis Thomsen

MD

Herlev Hospital

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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: Rocuronium

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.

Intervention: Succinylcholine

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.

Intervention: Cisatracurium

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.

Intervention: Mivacurium

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.

Intervention: Objective neuromuscular monitoring (acceleromyography)

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.

Intervention: Sugammadex

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.

Intervention: Neostigmine

Outcomes

Primary Outcomes

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

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

  • 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)
  • 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)

Study Sites (1)

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