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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Deep Neuromuscular Block | Experimental | Deep Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring [Post-Tetanic count (PTC): ≥1; Train of Four (TOF) Count: 0] |
|
| Arm 2: Moderate Neuromuscular Block | Active Comparator | Moderate Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring [Train of Four (TOF) Count: 1-3] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kubilay G YILMAZ | Contact | +90 537 274 16 72 | kgyilmaz91@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Çankaya | 06530 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37555115 | Background | 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. | |
| 36520073 | Background |
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| From immediately after extubation and until 30 minutes after arrival to PACU |
| 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. |
| 33002927 | Background | 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. |
| 33934595 | Background | 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. |
| 26947624 | Background | 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. |
| 28828361 | Background | 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. |
| 25693014 | Background | 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. |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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