MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 8
- Primary Endpoint
- Abdominal working space
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
No Rocuronium
Phase 1: no neuromuscular blockade
Intervention: No Rocuronium (Procedure)
Rocuronium (moderate NMB)
Phase 2: moderate neuromuscular blockade (TOF 1-3)
Intervention: Rocuronium (moderate NMB) (Drug)
Rocuronium (deep NMB)
Phase 3: deep neuromuscular blockade (PTC 0-1)
Intervention: Rocuronium (deep NMB) (Drug)
Outcomes
Primary Outcomes
Abdominal working space
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
Skin-sacral promontory distance, measured by MRI
Secondary Outcomes
- 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)