MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy

Study Overview
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Brief Summary
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During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum. Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the quality of the surgical space conditions during laparoscopy (1), showed that compared to moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2). In this prospective cohort study, we will assess the influence of deep neuromuscular blockade on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for laparoscopic donor nephrectomy

Detailed Description
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Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal working space during laparoscopy. Study design: A single center prospective cohort study Study population: 10 adult patients (18 years or older), equally distributed by gender, scheduled for laparoscopic donor nephrectomy Study procedures: Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12 mmHg). Each patient will have a MRI scan during 3 stages: Phase 1: No neuromuscular blockade (TOF ratio 1) Phase 2: moderate neuromuscular blockade(TOF 1-3). Phase 3: deep neuromuscular blockade (PTC 0-1) Primary outcome: The abdominal space measured by MRI: Skin - sacral promontory distance Secondary outcome: 3D volume measurement of the abdominal cavity by MRI.

Official Title
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MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.

Conditions
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Neuromuscular Block, Surgery

Intervention / Treatment
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* Procedure: No Rocuronium
* Drug: Rocuronium (moderate NMB)
* Drug: Rocuronium (deep NMB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for laparoscopic donor nephrectomy obtained informed consent Exclusion Criteria: Unable to provide informed consent known or suspect allergy to mivacurium, rocuronium or sugammadex neuromuscular disease indication for rapid sequence induction Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy) BMI>30 kg/m2 American Society of Anesthesiologists (ASA) classification >2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each patient wil serve as its own control: Each patient will start without neuromuscular blockade (phase 1), followed by moderate neuromuscular blockade (phase 2) and deep neuromuscular blockade (phase 3).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No Rocuronium<br>Phase 1: no neuromuscular blockade | Procedure: No Rocuronium<br>* Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.<br>* Other names: No neuromuscular blockade;|
| Experimental: Rocuronium (moderate NMB)<br>Phase 2: moderate neuromuscular blockade (TOF 1-3) | Drug: Rocuronium (moderate NMB)<br>* Phase 2: Rocuronium will be titrated to a moderate NMB (TOF 1-3), monitored by TOF-watch. When an adequate moderate NMB is achieved, the patient will undergo a second MRI-abdomen.<br>* Other names: Moderate neuromuscular blockade (Rocuronium);|
| Experimental: Rocuronium (deep NMB)<br>Phase 3: deep neuromuscular blockade (PTC 0-1) | Drug: Rocuronium (deep NMB)<br>* Phase 3: The patient receives a bolus of 1.2 mg/kg rocuronium (adjusted to ideal body weight), to assure a deep or intense NMB (PTC 0-1). Then the patient will undergo the final, third MRI scan of the abdomen.<br>* Other names: Deep neuromuscular blockade (Rocuronium);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal working space | Skin-sacral promontory distance, measured by MRI | 3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal volume | 3D volume abdominal cavity, measured by MRI | 3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal working space, Moderate neuromuscular blockade, Deep neuromuscular blockade, MRI measurement, Laparoscopic surgery