NCT03497923: MagNeoSug

Interaction Between Magnesium and Neostigmine or Sugammadex for the Reversal of a Rocuronium-induced Neuromuscular Block

Completed Phase 4 Last updated 18 April 2023

What this trial tests

Phase 4 trial testing Magnesium Sulfate in Neuromuscular Blockade in 48 participants. Completed in 13 April 2023.

Timeline

11 February 2019

Primary endpoint
12 April 2023

13 April 2023

Quick facts

Lead sponsor	Christoph Czarnetzki
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	11 February 2019
Primary completion	12 April 2023
Estimated completion	13 April 2023
Sites	2 locations across Switzerland

Drugs / interventions tested

• Magnesium Sulfate — full drug profile →

Conditions studied

• Neuromuscular Blockade — all drugs for Neuromuscular Blockade →

Sponsor

Christoph Czarnetzki

Who can join

Adults 18 to 65, any sex, with Neuromuscular Blockade. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Magnesium sulphate is regularly used in perioperative medicine. During and after general anesthesia, it enhances the effect of muscle relaxants because it reduces the liberation of acetylcholine at the neuromuscular junction. When administered immediately after spontaneous recovery of a neuromuscular block (NMB), magnesium may cause a recurrence of NMB and compromise patient safety.

Rocuronium is a neuromuscular blocking agent which is frequently used to facilitate intubating and surgical conditions. At the end of the procedure, there are two ways to accelerate the reversal of a neuromuscular block induced by rocuronium: 1. Administration of neostigmine, an anticholinesterase agent and competitive antagonist; 2. Administration of sugammadex, a γ-cyclodextrin compound and specific encapsulator of rocuronium.

The study is done in patients receiving rocuronium and either neostigmine or sugammadex for reversal of NMB. It is hypothesized that when sugammadex is used as an antagonist of a rocuronium-induced NMB, it prevents the reappearance of NMB when magnesium is injected, because sugammadex should inactivate all remaining rocuronium molecules and restore neuromuscular reserve of the neuromuscular junctions. Further more it is hypothesized that reversal with neostigmine will not prevent a magnesium-induced recurrence of NMB to the same extent. The primary objective of the study is to show that after reversal with sugammadex there is no or only very little re-occurrence of neuromuscular block after a magnesium perfusion. Furthermore we want to show that after reversal with neostigmine there is a re-occurrence of neuromuscular block.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.