Serum Tryptase Concentration During General Anaesthesia W... | NCT04035707

Studies
Serum Tryptase Concentration During General Anaesthesia With Rocuronium

NCT04035707

Sponsor

Medical University of Bialystok

Status

Completed

Last Update Posted

Jul 29, 2019Actual

Enrollment

126Actual

Phase

Not Applicable

Conditions

Hypersensitivity Reaction

Interventions

Rocuronium
general volatile anaesthesia

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2009Actual

Primary Completion Date

Jun 25, 2010Actual

Completion Date

May 15, 2014Actual

First Submitted Date

Jul 11, 2019

First Submission Date that Met QC Criteria

Jul 25, 2019

First Posted Date

Jul 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2019

Last Update Posted Date

Jul 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium	Drug	using rocuronium as a relaxants during general anaesthesia	anaesthesia with rocuronium

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

steroid therapy, allergy in medical history, mastocytosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urszula Kosciuczuk	Medical University in Bialystok	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32785569	Derived	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.

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds