Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04035707

Enrollment

126

Registered

2019-07-29

Start date

2009-06-25

Completion date

2014-05-15

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity Reaction

Keywords

general anaesthesia, mast cell, rocuronium, tryptase

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 .

Interventions

DRUGRocuronium

using rocuronium as a relaxants during general anaesthesia

DRUGgeneral volatile anaesthesia

method of anaesthesia

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

qualification according surgical operation

Intervention model description

The study included 126 women given a general volatile anesthesia: group I - 66 - using the rocuronium and group II - 60 - without neuromuscular relaxants. Informations about perioperative fluid therapy and doses of rocuronium were noticed. The blood samples were collected to perform tryptase concentration analysis: preoperatively - before anesthesia and postoperatively - after recovery from anesthesia.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* steroid therapy, allergy in medical history, mastocytosis

Design outcomes

Primary

Measure	Time frame	Description
tryptase	up to 40 minutes after surgery	serum tryptase concentration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026