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Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.

NCT01930747 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-05-29

Study results available
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Summary

The objective of this study is to compare the value of deep neuromuscular block (NMB) (using rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 minimum alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon.

The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points allow to calculate the abdominal compliance and the pressure at zero volume (PV0).

Conditions

  • Muscle Relaxation

Interventions

DRUG

rocuronium

measure effect on laparoscopic workspace

DRUG

Sevoflurane

1 MAC sevoflurane inhalation is given

DRUG

remifentanyl

remifentanyl is given in infusion

Sponsors & Collaborators

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Jan P Mulier, PhD · azsintjan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • Belgium

Study Locations

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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 NCT01930747 on ClinicalTrials.gov