Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 25, 2010

Detailed Description

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 .

Interventions

  • Drug: Rocuronium
    • using rocuronium as a relaxants during general anaesthesia
  • Drug: general volatile anaesthesia
    • method of anaesthesia

Arms, Groups and Cohorts

  • Experimental: anaesthesia with rocuronium
    • rocuronium is used during anaesthesia
  • Experimental: anaesthesia without rocuronium
    • during anaesthesia rocuronium is not used

Clinical Trial Outcome Measures

Primary Measures

  • tryptase
    • Time Frame: up to 40 minutes after surgery
    • serum tryptase concentration

Participating in This Clinical Trial

Inclusion Criteria

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

  • steroid therapy, allergy in medical history, mastocytosis

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Bialystok
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Urszula Kosciuczuk, Principal Investigator, Medical University in Bialystok

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.