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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Refusal to participate in the study

ASA ≥ IV

Age <18

Obesity (BMI>30) and cachexia (BMI <18)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Arm 1: Deep Neuromuscular BlockExperimental treatment 1 intervention
Group B: Arm 2: Moderate Neuromuscular BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

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