Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Not Applicable

Completed

• Conditions: Hypersensitivity Reaction
• Interventions: Drug: Rocuronium; Drug: general volatile anaesthesia

• Registration Number: NCT04035707
• Lead Sponsor: Medical University of Bialystok

Brief 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.

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 .

Study Timeline

• Study Start: 2009-06-25
• Primary Completion: 2010-06-25
• Study Completion: 2014-05-15
• Status Verified: 2019-07
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Study First Posted: 2019-07-29
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

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

Exclusion Criteria

• steroid therapy, allergy in medical history, mastocytosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anaesthesia with rocuronium	Rocuronium	rocuronium is used during anaesthesia
anaesthesia with rocuronium	general volatile anaesthesia	rocuronium is used during anaesthesia
anaesthesia without rocuronium	general volatile anaesthesia	during anaesthesia rocuronium is not used

Primary Outcome Measures

Name	Time	Method
tryptase	up to 40 minutes after surgery	serum tryptase concentration