Serum Tryptase Concentration During General Anaesthesia With Rocuronium

NCT04035707 | Completed

• 1 other identifier: 143-14548/14
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersensitivity Reaction

Keywords

general anaesthesia; mast cell; rocuronium; tryptase

Outcome Measures

Primary Outcomes (1)

• tryptase

  serum tryptase concentration

  up to 40 minutes after surgery

Study Arms (2)

anaesthesia with rocuronium

EXPERIMENTAL

rocuronium is used during anaesthesia

Drug: Rocuronium; Drug: general volatile anaesthesia

anaesthesia without rocuronium

EXPERIMENTAL

during anaesthesia rocuronium is not used

Drug: general volatile anaesthesia

Interventions

Rocuronium DRUG

using rocuronium as a relaxants during general anaesthesia

anaesthesia with rocuronium

general volatile anaesthesia DRUG

method of anaesthesia

anaesthesia with rocuronium; anaesthesia without rocuronium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• steroid therapy, allergy in medical history, mastocytosis

Sponsors & Collaborators

• Medical University of Bialystok: lead

Related Publications (1)

• 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.

  PMID: 32785569 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Urszula Kosciuczuk

  Medical University in Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: qualification according surgical operation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 29, 2019
• Study Start: June 25, 2009
• Primary Completion: June 25, 2010
• Study Completion: May 15, 2014
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share