CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
Neostigmine +2 moredrug
Likely dose
Neostigmine 0.06 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02284412
NCT02284412Phase 4Completed

Visualization of Regional Lung Ventilation During Neostigmine or Sugammadex Enhanced Recovery From Moderate Residual Neuromuscular Blockade in the Anaesthetized Rat Using Functional Respiratory Imaging

Onze Lieve Vrouw Hospital·interventional·Posted Nov 6, 2014·Updated Apr 21, 2015

In Brief

A Phase 4 clinical trial evaluating Neostigmine, Sugammadex, and 1 other intervention for Respiratory-Gated Imaging Techniques. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The use of neuromuscular blocking agents (NMBAs) is still associated with postoperative pulmonary complications. The investigators rely on acceleromyography (AMG) of a peripheral nerve/muscle to assess the patients' breathing capability at the end of surgery. It is possible that respiratory complications after surgery (e.g. desaturation and atelectasis) are related to the lack of diaphragm activity. A previous trial by our study group links the use of sugammadex, a novel selective relaxant binding agent (SRBA) for reversal of neuromuscular blockade, to an increase in diaphragm electrical activity, compared to reversal with neostigmine. Our hypothesis is that by making nicotinergic acetylcholine receptors free from rocuronium in the diaphragmatic neuromuscular junctions, instead of increasing the amount of acetylcholine (like neostigmine does), sugammadex will result in a better neuromuscular coupling. This may have its subsequent effects on the central control of breathing, influencing the balance between intercostal and diaphragm activity. The investigators now propose a study in rats, where the investigators will use Functional Respiratory Imaging (FRI, property of FluidDA n.v., Groeningenlei 132, B-2550 Kontich) to assess regional lung ventilation after sugammadex, neostigmine or spontaneous reversal. The images obtained through micro-CT scans allow us to accurately reconstruct airway morphology in the free-breathing rat. It will provide us with new insights into breathing physiology after reversal of neuromuscular blockade.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 6, 2014
Enrollment StartDec 1, 2014
Primary CompletionDec 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.7 years ago

Interventions

Neostigminedrug

At a train-of-four (TOF) ratio of 0.5: administration of neostigmine 0.06 mg/kg for reversal of neuromuscular blockade.

Sugammadexdrug

At a train-of-four (TOF) ratio of 0.5: administration of sugammadex 15 mg/kg for reversal of neuromuscular blockade.

Water for injectiondrug

At a train-of-four (TOF) ratio of 0.5: administration of placebo for spontaneous recovery of neuromuscular blockade.