Back to resultsSerum Tryptase Concentration During General Anaesthesia With Rocuronium
Primary Purpose
Hypersensitivity Reaction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rocuronium
general volatile anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Hypersensitivity Reaction focused on measuring general anaesthesia, mast cell, rocuronium, tryptase
Eligibility Criteria
Inclusion Criteria:
- ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia
Exclusion Criteria:
- steroid therapy, allergy in medical history, mastocytosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
anaesthesia with rocuronium
anaesthesia without rocuronium
Arm Description
rocuronium is used during anaesthesia
during anaesthesia rocuronium is not used
Outcomes
Primary Outcome Measures
tryptase
serum tryptase concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT04035707
First Posted
July 11, 2019
Last Updated
July 25, 2019
Sponsor
Medical University of Bialystok
1. Study Identification
Unique Protocol Identification Number
NCT04035707
Brief Title
Serum Tryptase Concentration During General Anaesthesia With Rocuronium
Official Title
Serum Tryptase Concentration During General Anaesthesia With Rocuronium
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2009 (Actual)
Primary Completion Date
June 25, 2010 (Actual)
Study Completion Date
May 15, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity Reaction
Keywords
general anaesthesia, mast cell, rocuronium, tryptase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
qualification according surgical operation
Allocation
Non-Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anaesthesia with rocuronium
Arm Type
Experimental
Arm Description
rocuronium is used during anaesthesia
Arm Title
anaesthesia without rocuronium
Arm Type
Experimental
Arm Description
during anaesthesia rocuronium is not used
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
using rocuronium as a relaxants during general anaesthesia
Intervention Type
Drug
Intervention Name(s)
general volatile anaesthesia
Intervention Description
method of anaesthesia
Primary Outcome Measure Information:
Title
tryptase
Description
serum tryptase concentration
Time Frame
up to 40 minutes after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia
Exclusion Criteria:
steroid therapy, allergy in medical history, mastocytosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urszula Kosciuczuk
Organizational Affiliation
Medical University in Bialystok
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD are available only for investigators
Citations:
PubMed Identifier
32785569
Citation
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.
Results Reference
derived
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Serum Tryptase Concentration During General Anaesthesia With Rocuronium
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