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

NCT02914119 | Completed Results DMC

• 1 other identifier: JLT-NM4
• Study Type: observational
• Target: 30,430
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuromuscular Blockade

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (1)

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

Rocuronium DRUG

Eligible patients

Succinylcholine DRUG

Eligible patients

Cisatracurium DRUG

Eligible patients

Mivacurium DRUG

Eligible patients

Objective neuromuscular monitoring (acceleromyography) DEVICE

Eligible patients

Sugammadex DRUG

Eligible patients

Neostigmine DRUG

Eligible patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received general anaesthesia with neuromuscular blockade

You may qualify if:

• 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

Sponsors & Collaborators

• Jakob Louis Thomsen: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Herlev Hospital

Herlev, Denmark

Location

MeSH Terms

Interventions

Rocuronium; Succinylcholine; cisatracurium; Mivacurium; Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds

Results Point of Contact

• Title: Dr. JLD Thomsen
• Organization: Herlev Hospital, research unit, anesthesia

prs@demants.dk

004538633863

Study Officials

• Jakob L Thomsen, MD

  Sponsor principal investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)