Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Study Overview
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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 .

Official Title
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Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Conditions
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Hypersensitivity Reaction

Intervention / Treatment
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* Drug: Rocuronium
* Drug: general volatile anaesthesia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anaesthesia with rocuronium<br>rocuronium is used during anaesthesia | Drug: Rocuronium<br>* using rocuronium as a relaxants during general anaesthesia<br>Drug: general volatile anaesthesia<br>* method of anaesthesia<br>|
| Experimental: anaesthesia without rocuronium<br>during anaesthesia rocuronium is not used | Drug: general volatile anaesthesia<br>* method of anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tryptase | serum tryptase concentration | up to 40 minutes after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anaesthesia, mast cell, rocuronium, tryptase