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

Not Applicable

• Conditions: Neuromuscular Block; Surgery
• Interventions: Drug: Rocuronium (moderate NMB); Drug: Rocuronium (deep NMB); Procedure: No Rocuronium

• Registration Number: NCT03287388
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-19
• Status Verified: 2018-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02
• Study Start: 2019-05
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• scheduled for laparoscopic donor nephrectomy
• obtained informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rocuronium (moderate NMB)	Rocuronium (moderate NMB)	Phase 2: moderate neuromuscular blockade (TOF 1-3)
Rocuronium (deep NMB)	Rocuronium (deep NMB)	Phase 3: deep neuromuscular blockade (PTC 0-1)
No Rocuronium	No Rocuronium	Phase 1: no neuromuscular blockade

Primary Outcome Measures

Name	Time	Method
Abdominal working space	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	Skin-sacral promontory distance, measured by MRI

Secondary Outcome Measures

Name	Time	Method
Abdominal volume	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	3D volume abdominal cavity, measured by MRI