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

NCT03287388 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-04-02

No results posted yet for this study

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

Interventions

PROCEDURE

No Rocuronium

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

DRUG

Rocuronium (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.

DRUG

Rocuronium (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 & Collaborators

Principal Investigators

  • Michiel C Warlé, Dr. · Radboud University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2019-11-30
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287388 on ClinicalTrials.gov