Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Medical University of Bialystok

Status: Completed

Conditions: Hypersensitivity Reaction

Treatments: Drug: Rocuronium; Drug: general volatile anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04035707

143-14548/14

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 126 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• steroid therapy, allergy in medical history, mastocytosis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

anaesthesia with rocuronium

Experimental group

Description:

rocuronium is used during anaesthesia

Treatment:

Drug: Rocuronium

Drug: general volatile anaesthesia

anaesthesia without rocuronium

Experimental group

Description:

during anaesthesia rocuronium is not used

Treatment:

Drug: general volatile anaesthesia