Intraoperative Neuromuscular Blockade and Postoperative Atelectasis

August 18, 2021 updated by: Hyungseok Seo, Kyung Hee University Hospital at Gangdong

The Effect of Intraoperative Neuromuscular Blockade on Postoperative Atelectasis in Patients Undergoing Thoracic Surgery With One Lung Ventilation: Moderate vs. Deep Block

During one-lung ventilation in thoracic surgery, the intensity of neuromuscular blockade may change the compliance and resistance of ventilated lung, thereby affecting postoperative atelectasis. The present study investigated the effect of the intensity of intraoperative neuromuscular blockade on the postoperative atelectasis using chest computerized tomography in patients receiving thoracic surgery requiring one-lung ventilation.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neuromuscular blocking agents can be used to secure a good surgical field, but it can also cause delayed extubation or postoperative pulmonary complications. Traditionally, rocuronium which is a commonly used non-depolarizing agent is usually reversed by cholinesterase inhibitors such as neostigmine or pyridostigmine. These drugs act by increasing the concentration of acetylcholine at the neuromuscular junction (a competing antagonist), not by direct antagonists. Consequently, there is a risk of pulmonary complications when cholinesterase inhibitor is not used appropriately. Use of sugammadex can reverse neuromuscular blockade (NMB) quickly, thereby being helpful for spontaneous deep breathing postoperatively. In a previous study, the moderate neuromuscular blockade was not guaranteed during surgery because intraoperative train-of-four (TOF) monitoring was not used and the outcome was focused on the correlation between reversal agent and the overall incidence of postoperative pulmonary complications. However, in the present study, TOF ratio or post-tetanic count (PTC) was repeatedly measured during surgery, thereby the intensity of intraoperative NMB being maintained. Moreover, lung compliance was repeatedly measured during surgery and the correlation between the intensity of intraoperative NMB and postoperative atelectasis which is evaluated by quantitative technique was also investigated.

Particularly in thoracic surgery, one lung ventilation is usually required for the surgical procedure. During one-lung ventilation, the compliance of ventilated lung is decreased and resistance can be increased, thereby the risk of atelectasis being increased. Furthermore, after thoracic surgery, although patients were encouraged to deep breathe, it is difficult to take a deep breath because of various factors. (i.e. pain, chest tube, long retracted time, postoperative interstitial edema, etc.) Therefore, postoperative atelectasis is much more important in patients undergoing thoracic surgery than other types of surgery.

For preventing postoperative atelectasis, the intraoperative intensity of neuromuscular blockade can be a crucial factor. Because deep neuromuscular blockade provides a good lung compliance during mechanical ventilation, peak inspiratory pressure can be decreased, thereby reducing the risk of ventilation-induced lung injury, particularly in one lung ventilation situation.However, there has been still lack of quantitative evidence that deep block is superior to moderate block in the thoracic surgery with one-lung ventilation

For assessment of postoperative atelectasis, plain chest radiography may be used. However, plain chest radiography can provide only a qualitative assessment of atelectasis. Computed tomography can assess the whole lung by its density (HU) and enables a quantitative assessment of postoperative atelectasis. Moreover, it can indicate the location of atelectasis more clearly than plain chest radiography, thus provide detailed information about postoperative lung state. To assess the effect of maintaining deep block and sugammadex reversal on the postoperative atelectasis, using chest CT can provide a much more quantitative and valuable information than conventional chest radiography.

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.
118

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05278
        • Kyung Hee University Gangdong Hospital

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving open or thoracoscopic lobectomy, bi-lobectomy, or sleeve lobectomy.

Description

Inclusion Criteria:

  1. Patients receiving scheduled unilateral lung lobectomy.
  2. Patients age ≥19
  3. Patients of American Society of Anesthesiologist Physical Status 1 or 2

Exclusion Criteria:

  1. Patients receiving bilateral lung lobectomy
  2. Patients BMI > 35.0 or < 18.5 kg/m2
  3. Patients of contraindicated to epidural patients controlled analgesia
  4. Patients with neuromuscular disease (i.e. myasthenia gravis)
  5. Patients with major burn (more than 3rd degrees)
  6. Patients with compromised cardiopulmonary function.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Moderate block group
maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery
Procedure: intraoperative neuromuscular blockade
The intensity of intraoperative neuromuscular blockade
Deep block group
maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery
Procedure: intraoperative neuromuscular blockade
The intensity of intraoperative neuromuscular blockade

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
Atelectasis Area on Chest CT
Time Frame: 1 day after the end of surgery
Atelectasis on Chest CT The lung area was delineated manually. To calculate atelectasis, a region of interest was laid out that encircled the dense part of the lung, excluding large vessels. For further analysis, the lung was divided into four categories: areas with densities ranging from -1000 to -900 Hounsfield units (HU) were classified as over-aerated, from -900 to -500 HU as normally aerated, from -500 to -100 HU as poorly aerated, and from -100 to +100 HU as non-aerated (atelectasis). The proportion of non-aerated lung tissue (-100 to +100 HU) was calculated by dividing the area of the region of interest with the whole lungs.
1 day after the end of surgery

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
Number of Patients Defined as Acute Respiratory Distress Syndrome
Time Frame: up to 7 days after the end of surgery

Acute respiratory distress syndrome can be defined as follows;

Bilateral opacities not fully explained by effusions, lobar/lung collapse or nodules on chest radiograph or CT scan and Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic edema if no risk factor present and Partial pressure of pulmonary arterial oxygen / Oxygen friction < 300 mmHg with positive end-expiratory pressure or continuous positive airway pressure of 5 cmH2O.
up to 7 days after the end of surgery
Number of Patients Defined as Pneumonia
Time Frame: up to 7 days after the end of surgery

Pneumonia can be defined as follows;

Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):

  1. new or progressive and persistent infiltrates
  2. consolidation
  3. cavitation; at least one of the following

1) fever (>38.0 C) with no other recognized cause 2) White blood cell count < 4000/ml or >12,000/ml 3) for adults >70 yr, altered mental status with no other recognized cause; and at least two of the following

  1. new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
  2. new onset or worsening cough, or dyspnea, or tachypnea
  3. crackles or bronchial breath sounds
  4. worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
up to 7 days after the end of surgery
Number of Patients Showing Pleural Effusion
Time Frame: 1 day after the end of surgery
Pleural effusion can be diagnosed on postoperative radiograph imaging.
1 day after the end of surgery
Number of Patients Showing Postoperative Desaturation
Time Frame: up to 1 day after surgery completed
The number of patients showing desaturation (SpO2 <95%) in room air.
up to 1 day after surgery completed
Number of Patients Requiring Postoperative Re-intubation
Time Frame: up to 1 day after surgery completed
The number of patients requiring re-intubation due to postoperative respiratory difficulty.
up to 1 day after surgery completed
Intraoperative Lung Compliance (ml/cmH2O)
Time Frame: every 1 hour from the time of the tracheal intubation to the end of the skin closure.
Intraoperative lung compliance (ml/cmH2O) can be calculated with peak inspiratory pressure or plateau pressure, positive end-expiratory pressure and tidal volume.
every 1 hour from the time of the tracheal intubation to the end of the skin closure.
Patient Demographic Data
Time Frame: on the day of admission
Age in years, Gender, Weight in kilograms, Height in centimeters
on the day of admission

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.
Kyung Hee University Hospital at Gangdong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 11, 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.
May 14, 2020

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.
May 18, 2021

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).
April 6, 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.
April 18, 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.
April 20, 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.
August 20, 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.
August 18, 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.
August 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 2018-03-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Thoracic Surgery

Clinical Trials on intraoperative neuromuscular blockade

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings