NCT03417804

Brief Summary

This is an epidemiological multicenter, observational, prospective study, designed to determine the incidence of postoperative residual neuromuscular blockade - defined by a TOF (train-of-four) ratio \< 0.9 - at PACU arrival. Subjects aged at least 18 years old (n=360) admitted for different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents will be included.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 6, 2021

Completed
Last Updated

July 6, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

January 25, 2018

Results QC Date

May 11, 2021

Last Update Submit

June 14, 2021

Conditions

Residual Neuromuscular BlockadeResidual Paralysis, Post-AnesthesiaObservational StudyComplication of AnesthesiaNeuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Postoperative Residual Neuromuscular Blockade

    Percentage of patients arriving PACU with a TOF ratio \< 0.9 measured as average of 3 consecutive TOF stimulations

    No more than 10 minutes after operating room exit

Secondary Outcomes (3)

  • Percentage of Patients With Severe Residual Postoperative Neuromuscular Blockade

    no more than 10 minutes after operating room exit

  • Association of Postoperative Residual Blockade and the Use of Reversal Agents

    no more than 10 minutes after operating room exit

  • Association of Postoperative Residual Blockade and the Use of Intra-operative Monitoring of Neuromuscular Blockade

    no more than 10 minutes after operating room exit

Other Outcomes (1)

  • Association of Postoperative Residual Blockade and ASA Status

    no more than 10 minutes after operating room exit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for surgery on 10 centers that accepted to participate in the study.

You may qualify if:

  • years of age or older;
  • Informed consent signed;
  • Admission for elective surgery;
  • Administration of non-depolarizing NMBAs during surgery

You may not qualify if:

  • Admission for emergency surgery;
  • Reoperation on the same hospital admission;
  • More than 10 minutes elapsed between extubation and neuromuscular block monitoring at PACU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital Prof. Fernando Fonseca, EPE

Amadora, 2720-276, Portugal

Location

Centro Hospitalar Baixo Vouga

Aveiro, Portugal

Location

Centro Hospitalar Universitário de Coimbra

Coimbra, Portugal

Location

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

Location

Hospital Pedro Hispano

Matosinhos Municipality, Portugal

Location

Centro Hospitalar Tamega Sousa

Penafiel, Portugal

Location

Centro Hospitalar do Porto

Porto, Portugal

Location

Centro Hospitalar S. João

Porto, Portugal

Location

Centro Hospitalar Vila Nova Gaia/Espinho

Vila Nova de Gaia, Portugal

Location

Centro Hospitalar Tondela Viseu

Viseu, Portugal

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to its observational nature, it was not possible to standardize practices between centres. A convenience sample was used (patients were included when investigators were scheduled to PACU), what may have biased the study sample

Results Point of Contact

Title
Dr. Simão Esteves
Organization
Centro Hospitalar do Porto
simao.esteves@me.com
+351222077549

Study Officials

  • Simao Esteves, MD

    Centro Hospitalar do Porto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 25, 2018

First Posted

January 31, 2018

Study Start

June 18, 2018

Primary Completion

July 16, 2019

Study Completion

November 1, 2019

Last Updated

July 6, 2021

Results First Posted

July 6, 2021

Record last verified: 2021-06

Locations

PT(10)