An interventional study of No Rocuronium and Rocuronium (moderate NMB) in Neuromuscular Block and Surgery, sponsored by Radboud University Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-02.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Phase 1: no neuromuscular blockade
Procedure: No Rocuronium
Phase 2: moderate neuromuscular blockade (TOF 1-3)
Drug: Rocuronium (moderate NMB)
Phase 3: deep neuromuscular blockade (PTC 0-1)
Drug: Rocuronium (deep NMB)
Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.
Also known as: No neuromuscular blockade
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.
Also known as: Moderate neuromuscular blockade (Rocuronium)
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.
Also known as: Deep neuromuscular blockade (Rocuronium)
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
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
No study locations are listed for this record.
Plan to share: Undecided
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Radboud University Medical Center