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

NCT03287388 | Unknown

• 1 other identifier: 63227.091.17
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Conditions

Neuromuscular Block; Surgery

Keywords

Laparoscopic surgery; Abdominal working space; Moderate neuromuscular blockade; Deep neuromuscular blockade; MRI measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

No Rocuronium

EXPERIMENTAL

Phase 1: no neuromuscular blockade

Procedure: No Rocuronium

Rocuronium (moderate NMB)

EXPERIMENTAL

Phase 2: moderate neuromuscular blockade (TOF 1-3)

Drug: Rocuronium (moderate NMB)

Rocuronium (deep NMB)

EXPERIMENTAL

Phase 3: deep neuromuscular blockade (PTC 0-1)

Drug: Rocuronium (deep NMB)

Interventions

No Rocuronium PROCEDURE

Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.

Also known as: No neuromuscular blockade

No Rocuronium

Rocuronium (moderate NMB) DRUG

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)

Rocuronium (moderate NMB)

Rocuronium (deep NMB) DRUG

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)

Rocuronium (deep NMB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for laparoscopic donor nephrectomy
• obtained informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (3)

• Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warle 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.

  PMID: 28575335 BACKGROUND

• 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.

  PMID: 24240315 BACKGROUND

• Krijtenburg P, Bruintjes MHD, Futterer JJ, van de Steeg G, d'Ancona F, Scheffer GJ, Keijzer C, Warle MC. MRI measurement of the effects of moderate and deep neuromuscular blockade on the abdominal working space during laparoscopic surgery, a clinical study. BMC Anesthesiol. 2023 Jul 14;23(1):238. doi: 10.1186/s12871-023-02201-1.

  PMID: 37452279 DERIVED

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michiel C Warlé, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moira HD Bruintjes, Msc.

CONTACT

(+)31-24-3617612; Moira.Bruintjes@radboudumc.nl

Piet Krijtenburg, Drs.

CONTACT

(+)31-24-3619032; Piet.Krijtenburg@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 19, 2017
• Study Start: May 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 2, 2019

Record last verified: 2018-04