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

NCT07464288 — Not applicable, Not yet recruiting, 128 participants, Ankara City Hospital Bilkent

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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

RegistryNCT07464288
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment128 (Estimated)
SponsorAnkara City Hospital Bilkent (Other)
ConditionsDriving Pressure, Neuromuscular Blockade Monitoring, Postoperative Respiratory Complications
InterventionsRocuronium (Drug)
Datesstart 2026-03-23 (estimated), primary completion 2026-04-23 (estimated), completion 2026-04-24 (estimated), first posted 2026-03-11, last updated 2026-03-17
Locations1 site in Turkey (Türkiye)

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-Summary

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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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Arm 1: Deep Neuromuscular BlockExperimentalDrug: RocuroniumDeep Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring \[Post-Tetanic count (PTC): ≥1; Train of Four (TOF) Count: 0\]
Arm 2: Moderate Neuromuscular BlockActive comparatorDrug: RocuroniumModerate Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring \[Train of Four (TOF) Count: 1-3\]
  • 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.

+Outcome measures

Primary outcomes

  • Mean Intraoperative Driving Pressure [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

  • Incidende of Postoperative Critical Respiratory Events [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).

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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)

+Locations (1)

FacilityCityCountryStatus
Ankara Bilkent City HospitalAnkara, ÇankayaTurkey (Türkiye)

+Publications

  • 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. PMID 37555115
  • 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. PMID 36520073
  • 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. PMID 33002927
  • Chaves-Cardona H, Hernandez-Torres V, Kiley S, Renew J. Neuromuscular blockade management in patients with COVID-19. Korean J Anesthesiol. 2021 Aug;74(4):285-292. doi: 10.4097/kja.21106. Epub 2021 May 3. PMID 33934595
  • 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. PMID 26947624
  • Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08. PMID 28828361
  • 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. PMID 25693014

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