Neuromuscular Block, Surgery
Conditions
Keywords
Laparoscopic surgery, Abdominal working space, Moderate neuromuscular blockade, Deep neuromuscular blockade, MRI measurement
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.
Interventions
PROCEDURENo Rocuronium
Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.
DRUGRocuronium (moderate NMB)
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.
DRUGRocuronium (deep NMB)
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.
Sponsors
Merck Sharp & Dohme LLC
Radboud University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMoira HD Bruintjes, Msc.
Backup ContactPiet Krijtenburg, Drs.
Outcome results
None listed