Effect of Neuromuscular Block Depth on Driving Pressure and Postoperative Respiratory Events in Abdominal Surgeries

March 15, 2026 updated by: ismail aytaç, Ankara City Hospital Bilkent

The Effect of Different Depths of Neuromuscular Blockade, Assessed by Train of Four (TOF) Monitoring, On Driving Pressure and the Development of Postoperative Critical Respiratory Events in Abdominal Surgeries

This randomized controlled study aims to evaluate the effects of deep versus moderate neuromuscular blockade on intraoperative driving pressure and the development of postoperative critical respiratory events in patients undergoing abdominal surgery under general anesthesia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Patients will be randomized into two groups:

Deep neuromuscular blockade group (TOF count 0, PTC 1-2) Moderate neuromuscular blockade group (TOF count 1-2) Driving pressure (Plateau pressure - PEEP) will be recorded intraoperatively. Postoperative critical respiratory events will be assessed within 30 minutes in the post anesthesia care unit (PACU).

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.
Interventional

Enrollment (Estimated)

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.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye), 06530
        • Ankara Bilkent City Hospital
        • Contact:
        • Principal Investigator:
          • İsmail AYTAÇ, Associate Professor

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Elective abdominal surgery under general anesthesia that is expected to last longer than one hour
  • ASA I-II-III
  • Age ≥18 years
  • Written informed consent

Exclusion Criteria:

  • Refusal to participate in the study
  • ASA ≥ IV
  • Age <18
  • Obesity (BMI>30) and cachexia (BMI <18)
  • Laparoscopic surgery
  • Emergency procedure
  • Allergy to drugs used during induction and maintenance of general anesthesia
  • Presence of psychiatric/neurologic/neuromuscular disease
  • Risk of malignant hyperthermia or having any relative with history of malignant hyperthermia
  • Use of medications that may affect neuromuscular function (anticonvulsants, aminoglycosides, magnesium salts, etc.)
  • Pregnancy
  • Presence of advanced chronic lung disease (asthma, COPD, etc.)
  • Presence of advanced liver and renal disease (creatinine>1.6, liver function tests above twice the normal range)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Arm 1: Deep Neuromuscular Block
Deep Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring [Post-Tetanic count (PTC): ≥1; Train of Four (TOF) Count: 0]
Drug: Rocuronium
Rocuronium will be administered intravenously as bolus and continuous infusion to achieve target neuromuscular blockade depth according to group allocation. Neuromuscular function will be monitored using quantitative TOF monitoring.
Active Comparator: Arm 2: Moderate Neuromuscular Block
Moderate Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring [Train of Four (TOF) Count: 1-3]
Drug: Rocuronium
Rocuronium will be administered intravenously as bolus and continuous infusion to achieve target neuromuscular blockade depth according to group allocation. Neuromuscular function will be monitored using quantitative TOF monitoring.

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
Mean Intraoperative Driving Pressure
Time Frame: From immediately after intubation until the end of surgery (intraoperative period)
Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure (PEEP) during volume-controlled ventilation. Measurements will be recorded at 30-minute intervals throughout surgery, and the mean value per patient will be calculated.
From immediately after intubation until the end of surgery (intraoperative period)

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
Incidende of Postoperative Critical Respiratory Events
Time Frame: From immediately after extubation and until 30 minutes after arrival to PACU
Critical respiratory events (CRE) include hypoxemia (hemoglobin oxygen saturation < 90%), hypoventilation (respiratory rate < 8 breaths/min or arterial carbon dioxide tension > 50 mmHg) or upper-airway obstruction (stridor or laryngospasm) requiring an active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, insertion of oral/nasal airway or airway manipulation).
From immediately after extubation and until 30 minutes after arrival to PACU

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.
Ankara City Hospital Bilkent

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 (Estimated)

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.
March 23, 2026

Primary Completion (Estimated)

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.
April 23, 2026

Study Completion (Estimated)

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.
April 24, 2026

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).
March 6, 2026

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.
March 6, 2026

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.
March 11, 2026

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.
March 17, 2026

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.
March 15, 2026

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.
March 1, 2026

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.
  • TABED 1-25-1139

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.

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