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July 1, 2003Alimentary Pharmacology & Therapeutics

The effect of metoclopramide on QT dynamicity: double‐blind, placebo‐controlled, cross‐over study in healthy male volunteers

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Why the study?

Does intravenous metoclopramide increase QT dynamicity in healthy male volunteers?

Population

10 healthy male volunteers

Comparison

Metoclopramide 10 mg administered intravenously vs Placebo administered intravenously

Design

RCT, at random, double-blind

Follow-up

30 minutes post-administration

Key result

Intravenous metoclopramide significantly increased the QT/RR slope (0.064 vs 0.037 pre-drug; P=0.041) and QT variance (P=0.023) in healthy male volunteers.

Authors

EEEnder EllidokuzDKDerya Kaya

Discussion

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Overview

IV metoclopramide warrants arrhythmia caution in clinical use; extends mechanistic evidence linking it to ventricular arrhythmia risk.

Study Design

Type

RCT (n=10)

Blinding

Double-blind

Randomization

Randomized

Structured PICO

Does intravenous metoclopramide increase QT dynamicity in healthy male volunteers?

P
Population
10 healthy male volunteers evaluated in a double-blind, placebo-controlled cross-over study to assess the effects of intravenous metoclopramide on QT dynamicity.
I
Intervention
Metoclopramide 10 mg administered intravenously
C
Comparator
Placebo administered intravenously
O
Outcome
Cardiac repolarization evaluated using QT dynamicity (QT/RR slopes and QT variance) during 30-min stationary segments before and after drug administrationsurrogate

Main Result

Absolute Event Rate: 0.064% vs 0.05%

p-value: p=0.041

Intravenous metoclopramide increases QT dynamicity in healthy male volunteers, providing a potential mechanistic explanation for its associated risk of ventricular arrhythmias.

Cite This Study

Ellidokuz et al. (2003) conducted an RCT in Healthy volunteers (n=10). Metoclopramide vs. Placebo was evaluated on QT/RR slope (p=0.041). Intravenous metoclopramide significantly increased the QT/RR slope (0.064 vs 0.037 pre-drug; P=0.041) and QT variance (P=0.023) in healthy male volunteers.

synapsesocial.com/papers/6a9aa423dd93ec450a0e5d0ahttps://doi.org/10.1046/j.1365-2036.2003.01641.x
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Also Consider

Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Long QT Syndrome During High-Dose Cisapride1995 · 165 citations
  2. 2Changes in Repolarization Dynamicity and the Assessment of the Arrhythmic Risk1997 · 47 citations
  3. 3Review article: cardiac adverse effects of gastrointestinal prokinetics1999 · 175 citations
  4. 4Autonomic mechanisms in ventricular fibrillation induced by myocardial ischemia during exercise in dogs with healed myocardial infarction. An experimental preparation for sudden cardiac death.1984 · 434 citations