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

N/ANot Yet RecruitingNCT07464288

Ankara City Hospital Bilkent128 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

128

Conditions

Driving Pressure Neuromuscular Blockade Monitoring Postoperative Respiratory Complications

Interventions

RocuroniumDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: From immediately after intubation until the end of surgery (intraoperative period)

Secondary Outcomes

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).

Time frame: From immediately after extubation and until 30 minutes after arrival to PACU

Central Contacts

Kubilay G YILMAZ

CONTACT

+90 537 274 16 72 kgyilmaz91@gmail.com

Data from ClinicalTrials.gov

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