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

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: Not yet recruiting
• Conditions: Postoperative Respiratory Complications; Driving Pressure; Neuromuscular Blockade Monitoring
• Intervention / Treatment: Drug: Rocuronium

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: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kubilay G YILMAZ; Phone Number: +90 537 274 16 72; Email: kgyilmaz91@gmail.com

Study Locations

• Turkey (Türkiye)
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye), 06530
      • Ankara Bilkent City Hospital
      • Contact: İsmail AYTAÇ, Associate Professor; Phone Number: +90 505 634 03 69; Email: aytacismail1972@gmail.com
      • Principal Investigator: İsmail AYTAÇ, Associate Professor

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mean Intraoperative Driving Pressure	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

Outcome Measure	Measure Description	Time Frame
Incidende of Postoperative Critical Respiratory Events	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

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
• Thilen SR, Weigel WA, Todd MM, Dutton RP, Lien CA, Grant SA, Szokol JW, Eriksson LI, Yaster M, Grant MD, Agarkar M, Marbella AM, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade: A Report by the American Society of Anesthesiologists Task Force on Neuromuscular Blockade. Anesthesiology. 2023 Jan 1;138(1):13-41. doi: 10.1097/ALN.0000000000004379.
• Zhang YW, Li Y, Huang WB, Wang J, Qian XE, Yang Y, Huang CS. Utilization of deep neuromuscular blockade combined with reduced abdominal pressure in laparoscopic radical gastrectomy for gastric cancer: An academic perspective. World J Gastrointest Surg. 2023 Jul 27;15(7):1405-1415. doi: 10.4240/wjgs.v15.i7.1405.
• Rezaiguia-Delclaux S, Laverdure F, Genty T, Imbert A, Pilorge C, Amaru P, Sarfati C, Stephan F. Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation. Anesth Analg. 2021 Apr 1;132(4):1051-1059. doi: 10.1213/ANE.0000000000005174.
• Chaves-Cardona H,Hernandez-Torres V,Kiley S,Renew J
• Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
• Tonetti T,Vasques F,Rapetti F,Maiolo G,Collino F,Romitti F,Camporota L,Cressoni M,Cadringher P,Quintel M,Gattinoni L

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2026
• Primary Completion (Estimated): April 23, 2026
• Study Completion (Estimated): April 24, 2026

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Steroids; Fused-Ring Compounds; Androstanes; Androstanols; Rocuronium
• Other Study ID 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