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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]

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

Condition category

Condition code

Anaesthesiology

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]

Treatment: Drugs

Comparator / control treatment

standard treatment (granisetron 1 mg)

Control group

Active

Outcomes

Primary outcome [1]

We will measure acceleromyographic response of ulnar nerve stimulation on m. pollicis brevis through TOF (train-of- four) value.

Timepoint [1]

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]

Blood rocuronium concentration (in both groups).

Timepoint [1]

Before sugammadex application and after full reversal of neuromuscular block according to TOF.

Secondary outcome [2]

Blood dexamethason concentration (in observational group).

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Slovenia

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

University Medical Center Ljubljana

Address [1]

Zaloska cesta 2, 1000 Ljubljana

Country [1]

Slovenia

Primary sponsor type

Hospital

Name

University Medical Center Ljubljana

Address

Zaloska cesta 2, 1000 Ljubljana

Country

Slovenia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Medical Ethics Committee of the Republic of Slovenia

Ethics committee address [1]

University Institute of Clinical Neurophysiology,
Medical Center Ljubljana,
Zaloska c. 7,
1525 Ljubljana,

Ethics committee country [1]

Slovenia

Date submitted for ethics approval [1]

01/02/2011

Approval date [1]

22/03/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Katja Rezonja

Address

Pribinova 7, 1000 Ljubljana

Country

Slovenia

Phone

+386 31 479 544

Fax

[email protected]

Contact person for scientific queries

Name

Katja Rezonja

Address

Pribinova 7, 1000 Ljubljana

Country

Slovenia

Phone

+386 31 479 544

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Dexamethasone does not diminish sugammadex reversal of neuromuscular block - clinical study in surgical patients undergoing general anesthesia.	2016	https://dx.doi.org/10.1186/s12871-016-0254-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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