Incidence of Postoperative Residual Neuromuscular Blockade in Portugal

June 14, 2021 updated by: Simao Esteves, Centro Hospitalar do Porto

Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a multicenter, observational/non-interventional study involving adult patients undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents.

The study will have two periods:

  • Period 1 - Evaluation at PACU arrival.
  • Period 2 - Collection of hospital patient discharge data.

A total of 360 patients will be included from approximately 10 centers in Portugal, where the PACU is adjacent to the Operating Room (OR). Each center should recruit between 30 and 40 patients.

Each subject is considered to be enrolled in the study when the subject has provided written informed consent.

Enrollment will be stopped when approximately 360 patients are recruited.

A subject is considered to have completed the trial after all of the protocol specified activities are completed. A subject is considered to have discontinued after he/she has withdrawn consent or has been discontinued.

Overall, study start is when the first site is initiated and study ends at database lock.

During the routine preoperative anesthesia visit the patient will be asked to participate in the study. A description of the study will be provided to the patient by the investigator or qualified designee and any questions will be properly answered. If the patient agrees to participate in the study an informed consent form (ICF) will be signed.

Consent must be documented by the subject's dated signature or by the subject's legally acceptable representative's dated signature on a consent form along with the dated signature of the person conducting the consent discussion. A copy of the signed and dated consent form should be given to the subject before participation in the study.

The initial informed consent form, any subsequent revised written informed consent form and any written information provided to the subject must receive the IRB/ERC's (Institutional Review Board) ) approval/favorable opinion in advance of use. The subject or his/her legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject's willingness to continue participation in the study.

All consented subjects will be given a unique patient number that will be used to identify the subject for all procedures. Each subject will be assigned only one patient number.

Immediately after patient arrival in the PACU and as soon as clinically adequate (basic monitoring and oxygen therapy in place) the anesthesiologist assigned to the PACU (who was not involved in the anesthetic procedure) will collect demographic data (gender, age, weight, height), vital signs (heart rate, blood pressure, oxygen saturation and temperature). Neuromuscular blockade (TOF Ratio) will be measured. Clinical history, co-morbidities, surgical diagnosis, ASA (American Society of Anesthesiology) classification and perioperative medication data (dosage and last administration time) will be collected as well.

As this is an observational study, intra-operative monitoring of neuromuscular blockade will not be mandatory by protocol and will be left at the discretion of the anesthesiologist as according to the clinical practice. Only information about whether this evaluation was performed or not, and if yes if it was used quantitative or qualitative methods, will be collected in the CRF (case report form) .

Neuromuscular blockade evaluation Neuromuscular blockade will be evaluated using a quantitative method. Three consecutive TOF stimulations will be applied. In case these 3 measures differ more than 20%, another sequence of 3 consecutive TOF measurements will be considered. If after the 2nd sequence the 3 consecutive TOF measurements still differ more than 20% between the maximum and the minimum the patient will be excluded.

This study will reflect real life clinical practice. The anesthetic technique in terms of drugs and type of monitoring used will be of entire responsibility of the anesthesiologist.

All study activities will be consistent with EU (European Union) directive 2001/20/EC section for non- interventional studies :

  • NMBAs (neuromuscular blocking agents) and reversal agents (as well as all drugs which will be used during the anesthesia) administration will be done in accordance with routine anesthesiology practice and labeling of these medicine products;
  • No further interventional means, methods or procedures, are scheduled for subjects, which would otherwise not be applied;
  • Furthermore, there will be no additional visits to the hospital or a mandatory visit schedule, deviating from daily clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Amadora, Portugal, 2720-276
        • Hospital Prof. Fernando Fonseca, EPE
      • Aveiro, Portugal
        • Centro Hospitalar Baixo Vouga
      • Coimbra, Portugal
        • Centro Hospitalar Universitario de Coimbra
      • Lisboa, Portugal
        • Centro Hospitalar Lisboa Norte
      • Matosinhos, Portugal
        • Hospital Pedro Hispano
      • Penafiel, Portugal
        • Centro Hospitalar Tamega Sousa
      • Porto, Portugal
        • Centro Hospitalar S. Joao
      • Porto, Portugal
        • Centro Hospitalar do Porto
      • Vila Nova De Gaia, Portugal
        • Centro Hospitalar Vila Nova Gaia/Espinho
      • Viseu, Portugal
        • Centro Hospitalar Tondela Viseu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Postoperative Residual Neuromuscular Blockade
Time Frame: No more than 10 minutes after operating room exit
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Severe Residual Postoperative Neuromuscular Blockade
Time Frame: no more than 10 minutes after operating room exit
Percentage of patients with severe postoperative residual neuromuscular blockade defined by a TOF ratio < 0.7
no more than 10 minutes after operating room exit
Association of Postoperative Residual Blockade and the Use of Reversal Agents
Time Frame: no more than 10 minutes after operating room exit
Association of postoperative residual blockade and the use of reversal agents (neostigmine, sugammadex or none)
no more than 10 minutes after operating room exit
Association of Postoperative Residual Blockade and the Use of Intra-operative Monitoring of Neuromuscular Blockade
Time Frame: no more than 10 minutes after operating room exit
To evaluate the 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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association of Postoperative Residual Blockade and ASA Status
Time Frame: no more than 10 minutes after operating room exit
To evaluate the association of postoperative residual blockade with co- morbidities and ASA status
no more than 10 minutes after operating room exit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Hospitalar do Porto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simao Esteves, MD, Centro Hospitalar do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017.156(133-DEFI/125-CES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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