Serum Tryptase Concentration During General Anaesthesia With Rocuronium

NCT ID: NCT04035707

Last Updated: 2019-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-25

Study Completion Date

2014-05-15

Brief Summary

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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

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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 .

Conditions

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Hypersensitivity Reaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
qualification according surgical operation

Study Groups

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anaesthesia with rocuronium

rocuronium is used during anaesthesia

Group Type EXPERIMENTAL

Rocuronium

Intervention Type DRUG

using rocuronium as a relaxants during general anaesthesia

general volatile anaesthesia

Intervention Type DRUG

method of anaesthesia

anaesthesia without rocuronium

during anaesthesia rocuronium is not used

Group Type EXPERIMENTAL

general volatile anaesthesia

Intervention Type DRUG

method of anaesthesia

Interventions

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Rocuronium

using rocuronium as a relaxants during general anaesthesia

Intervention Type DRUG

general volatile anaesthesia

method of anaesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* steroid therapy, allergy in medical history, mastocytosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Bialystok

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urszula Kosciuczuk

Role: PRINCIPAL_INVESTIGATOR

Medical University in Bialystok

References

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Kosciuczuk U, Knapp P, Jakubow P. Effect of body mass index and rocuronium on serum tryptase concentration during volatile general anesthesia: an observational study. Clinics (Sao Paulo). 2020;75:e1701. doi: 10.6061/clinics/2020/e1701. Epub 2020 Aug 10.

Reference Type DERIVED
PMID: 32785569 (View on PubMed)

Other Identifiers

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143-14548/14

Identifier Type: -

Identifier Source: org_study_id

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