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OpenTrials
Completed

NCT Number: NCT04035707

Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Rocuronium is a aminosteroid structured, non-depolarizing neuromuscular blocking agents (NMB). Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Determinations of serum tryptase concentrations are interdisciplinary recommended in diagnosis of its adverse reactions. No studies have been performed to explain specific role of rocuronium doses on serum tryptase values. The aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The greatest risk of hypersensitivity occurs during anesthesia for female patients and it is connected with the induction phase using skeletal muscle relaxants . Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Due to the multiple advantages reports of triggering allergic or hypersensitivity reactions caused by rocuronium create doubts about the safety of application .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia

Exclusion criteria

  • steroid therapy, allergy in medical history, mastocytosis

Treatment and study plan

Rocuronium

Drug

using rocuronium as a relaxants during general anaesthesia

general volatile anaesthesia

Drug

method of anaesthesia

Primary outcomes

  1. tryptase

    Time frame: up to 40 minutes after surgery

    serum tryptase concentration

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2014
First posted
Jul 29, 2019
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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