Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Hypersensitivity Reaction Clinical Trial

Official title:

Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04035707
• Other study ID #: 143-14548/14
• Status: Completed
• Phase: N/A
• Start date: June 25, 2009
• Est. completion date: May 15, 2014

Study information

• Verified date: July 2019
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 15, 2014
• Est. primary completion date: June 25, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• steroid therapy, allergy in medical history, mastocytosis

Related Conditions & MeSH terms

• Hypersensitivity
• Hypersensitivity Reaction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tryptase	serum tryptase concentration	up to 40 minutes after surgery