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Trial registered on ANZCTR


Registration number
ACTRN12612000245897
Ethics application status
Approved
Date submitted
27/02/2012
Date registered
28/02/2012
Date last updated
19/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of glucocorticoids on sugammadex action
Scientific title
A randomized parallel group study of glucocorticoids influence on sugammadex efficacy in patients anesthetized for elective surgery
Secondary ID [1] 280031 0
nil
Universal Trial Number (UTN)
U1111-1128-5104
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residual neuromuscular blockade 285946 0
Condition category
Condition code
Anaesthesiology 286134 286134 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will clinically evaluate (using TOF values) residual neuromuscular blockade after reversal with sugammadex in patients intraoperatively receiving glucocorticoids (dexamethasone 0,15 mg/kg i.v. at the end of the operation) for PONV prevention in comparison to individuals, receiving standard treatment (granisetron 1 mg i.v. after induction) - control group. Concurrently we will withdraw a blood sample before and after application of sugammadex to measure rocuronium and dexamethasone (in observation group) blood level.
Intervention code [1] 284356 0
Treatment: Drugs
Comparator / control treatment
standard treatment (granisetron 1 mg)
Control group
Active

Outcomes
Primary outcome [1] 286607 0
We will measure acceleromyographic response of ulnar nerve stimulation on m. pollicis brevis through TOF (train-of- four) value.
Timepoint [1] 286607 0
Measurements will start at the end of operation, just before i.v. application of sugammadex and will continue in 15 second intervals until full recovery of muscle strength (TOF value > 90%).
Secondary outcome [1] 296257 0
Blood rocuronium concentration (in both groups).
Timepoint [1] 296257 0
Before sugammadex application and after full reversal of neuromuscular block according to TOF.
Secondary outcome [2] 296258 0
Blood dexamethason concentration (in observational group).
Timepoint [2] 296258 0
Before sugammadex application and after full reversal of neuromuscular block according to TOF.

Eligibility
Key inclusion criteria
Patients anesthetized for elective surgery for which they need to be intubated and fully relaxed throughout the procedure, ASA I-III.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of consent, patients with neuromuscular disease, with anticipated difficult intubation, kidney failure, personal or family history of malignant hyperthermia, allergy to any anesthetics used, pregnant or nursing women, women taking oral contraceptives, patients receiving drugs that could interfere with sugammadex.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is decided and patients' informed consent is obtained by the author during preoperative roundings.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is done during anesthesia by drawing lots from an envelope containing 60 small pieces of paper, 30 marked dexamethason, 30 marked granisetron.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4174 0
Slovenia
State/province [1] 4174 0

Funding & Sponsors
Funding source category [1] 284788 0
Hospital
Name [1] 284788 0
University Medical Center Ljubljana
Country [1] 284788 0
Slovenia
Primary sponsor type
Hospital
Name
University Medical Center Ljubljana
Address
Zaloska cesta 2, 1000 Ljubljana
Country
Slovenia
Secondary sponsor category [1] 283673 0
None
Name [1] 283673 0
Address [1] 283673 0
Country [1] 283673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286779 0
National Medical Ethics Committee of the Republic of Slovenia
Ethics committee address [1] 286779 0
University Institute of Clinical Neurophysiology,
Medical Center Ljubljana,
Zaloska c. 7,
1525 Ljubljana,
Ethics committee country [1] 286779 0
Slovenia
Date submitted for ethics approval [1] 286779 0
01/02/2011
Approval date [1] 286779 0
22/03/2011
Ethics approval number [1] 286779 0
11/02/0161

Summary
Brief summary
Muscle relaxation has a significant role in general anesthesia, indications for the use of muscle relaxants (MR) are endotraheal intubation, surgical procedures on thorax and abdomen and microscopic surgery where it is necessary for patients to be fully relaxed. There are depolarising (succynilcholine) and nondepolarising (benzylisoquinolines, aminosteroids) MR. The reversal of neuromuscular blockade (NMB) at the end of anesthesia has to be achieved either by conventional acetylcholinesterase inhibitors (AChE inhibitors) or with new reversal agent sugammadex which introduced completely new concept of NMB reversal.Sugammadex encapsulates aminosteroid MR and therefore reduces the circulating MR concentration which by concentration gradient removes MR molecules from neuromuscular junction (NMJ). Complex sugammadex-MR is excreted in urine within 1-4 hours. Sugammadex therefore provides more rapid reversal of even deeper or more intensive NMB compared to broadly used AChE inhibitors. It is a drug of choice in reversing NMB in patients with neuromuscular disease (e.g. miasthenia gravis) and in patients with heart or lung disease in whom use of AChE inhibitors in less desirable due to their unfavorable side effects. Glucocorticoids are widely used agents as part of patient's daily regimen as well as an antiemetic agent during anaesthesia. The similarity of molecular structure of glucocorticoid and aminosteroid MR rises concerns whether the concurrent use of glucocorticoid could affect the efficiency of sugammadex.
In our prospective randomised study we will include 60 patients anesthetized for elective surgery (abdominal, thoracic). Patients enrolled into observational group will receive dexamethasone 0,15 mg/kg for prevention of postoperative nausea and vomiting (PONV), whereas patients in controlled group will receive granisetron 1 mg for the same purpose. Anesthesia will be conducted and maintained in standard fashion, muscle relaxation will be achieved using rocuronium, which will be added according to TOF (train of four) values. At the end of the operation we will draw the first sample of blood before application of sugammadex and the second one after regaining full muscle strength according to TOF. We will compare the blood levels of rocuronium (both groups) and dexamethasone (observational group) before and after sugammadex application which will allow us to indirectly evaluate possible dexamethasone encapsulation by sugammadex.
The aim of our study is to asess whether concurrent use of dexamethasone affects the efficacy of sugammadex.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33836 0
Address 33836 0
Country 33836 0
Phone 33836 0
Fax 33836 0
Email 33836 0
Contact person for public queries
Name 17083 0
Katja Rezonja
Address 17083 0
Pribinova 7, 1000 Ljubljana
Country 17083 0
Slovenia
Phone 17083 0
+386 31 479 544
Fax 17083 0
Email 17083 0
[email protected]
Contact person for scientific queries
Name 8011 0
Katja Rezonja
Address 8011 0
Pribinova 7, 1000 Ljubljana
Country 8011 0
Slovenia
Phone 8011 0
+386 31 479 544
Fax 8011 0
Email 8011 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDexamethasone does not diminish sugammadex reversal of neuromuscular block - clinical study in surgical patients undergoing general anesthesia.2016https://dx.doi.org/10.1186/s12871-016-0254-6
N.B. These documents automatically identified may not have been verified by the study sponsor.