Hypersensitivity ReactionNCT04035707
Serum Tryptase Concentration During General Anaesthesia With Rocuronium
A study testing Rocuronium and general volatile anaesthesia in people with Hypersensitivity Reaction, run by Medical University of Bialystok.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Hypersensitivity Reaction
- What is being tested?
- Rocuronium and general volatile anaesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2009to 15 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia
Who cannot join
- steroid therapy, allergy in medical history, mastocytosis
About this study
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.
Read the 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 .
- Conditions
- Hypersensitivity Reaction
- Being tested
- Rocuronium, general volatile anaesthesia
- Keywords
- general anaesthesia, mast cell, rocuronium, tryptase
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
using rocuronium as a relaxants during general anaesthesia
general volatile anaesthesiaDrug
method of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| anaesthesia with rocuronium | Experimental | rocuronium is used during anaesthesia Receives: Drug: Rocuronium; Drug: general volatile anaesthesia |
| anaesthesia without rocuronium | Experimental | during anaesthesia rocuronium is not used Receives: Drug: general volatile anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
tryptase
serum tryptase concentration
Measured: up to 40 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start25 Jun 2009
- Primary completion25 Jun 2010
- Study completion15 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urszula Kosciuczuk, Principal investigator, Medical University in Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035707
- Sponsor's protocol ID
- 143-14548/14
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are available only for investigators
Publications
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.
PubMed 32785569
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Tryptase Concentration During General Anaesthesia With Rocuronium
- ClinicalTrials.gov ID
- NCT04035707
- Acronym / sponsor ID
- 143-14548/14
- Conditions
- Hypersensitivity Reaction
- Keywords
- general anaesthesia, mast cell, rocuronium, tryptase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 25 Jun 2009 (actual)
- Primary completion
- 25 Jun 2010 (actual)
- Study completion
- 15 May 2014 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| anaesthesia with rocuronium | Experimental | Drug: Rocuronium, Drug: general volatile anaesthesiarocuronium is used during anaesthesia |
| anaesthesia without rocuronium | Experimental | Drug: general volatile anaesthesiaduring anaesthesia rocuronium is not used |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia
Key exclusion criteria (1 listed)
- steroid therapy, allergy in medical history, mastocytosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuroniumusing rocuronium as a relaxants during general anaesthesia | Drug | anaesthesia with rocuronium |
| general volatile anaesthesiamethod of anaesthesia | Drug | anaesthesia with rocuronium, anaesthesia without rocuronium |
Primary outcome
tryptase
Time frame: up to 40 minutes after surgery
serum tryptase concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 32785569Kosciuczuk 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.
- Individual participant dataSharing planned: No. IPD are available only for investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urszula Kosciuczuk principal investigator
Medical University in Bialystok
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium and general volatile anaesthesia in people with Hypersensitivity Reaction, run by Medical University of Bialystok.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tryptase (time frame: up to 40 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.