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NCT Number: NCT07464288

Effect of Neuromuscular Block Depth on Driving Pressure and Postoperative 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.

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Key information

Conditions

Driving Pressure Neuromuscular Blockade Monitoring Postoperative Respiratory Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06530, Turkey (Türkiye)

Location contact

İsmail AYTAÇ, Associate Professor

CONTACT

[email protected]

+90 505 634 03 69

İsmail AYTAÇ, Associate Professor

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rocuronium

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kubilay G YILMAZ

CONTACT

[email protected]

+90 537 274 16 72

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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