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

Radboud University Medical Center8 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

No RocuroniumPROCEDURE

Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.

Rocuronium (moderate NMB)DRUG

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.

Rocuronium (deep NMB)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Abdominal working space

Skin-sacral promontory distance, measured by MRI

Time frame: 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 Outcomes

Abdominal volume

3D volume abdominal cavity, measured by MRI

Time frame: 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