Surgery Clinical Trial
— RELAX-2Official title:
MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.
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
Status | Not yet recruiting |
Enrollment | 8 |
Est. completion date | December 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Merck Sharp & Dohme Corp. |
Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warlé MC. Deep neuromuscular block to optimize surgical space conditions during laparoscopic surgery: a systematic review and meta-analysis. Br J Anaesth. 2017 Jun 1;118(6):834-842. doi: 10.1093/bja/aex116. — View Citation
Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abdominal working space | Skin-sacral promontory distance, measured by MRI | 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 | |
Secondary | Abdominal volume | 3D volume abdominal cavity, measured by MRI | 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 |
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