MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy (RELAX-2)

Radboud University Medical Center

Status: Unknown

Conditions: Neuromuscular Block; Surgery

Treatments: Procedure: No Rocuronium; Drug: Rocuronium (moderate NMB); Drug: Rocuronium (deep NMB)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03287388

63227.091.17

Details and patient eligibility

About

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

Full description

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 3 patient groups

No Rocuronium

Experimental group

Description:

Phase 1: no neuromuscular blockade

Treatment:

Procedure: No Rocuronium

Rocuronium (moderate NMB)

Experimental group

Description:

Phase 2: moderate neuromuscular blockade (TOF 1-3)

Treatment:

Drug: Rocuronium (moderate NMB)

Rocuronium (deep NMB)

Experimental group

Description:

Phase 3: deep neuromuscular blockade (PTC 0-1)

Treatment:

Drug: Rocuronium (deep NMB)