ANZCTR - Registration

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621001449820

Ethics application status

Approved

Date submitted

30/07/2021

Date registered

25/10/2021

Date last updated

25/10/2021

Date data sharing statement initially provided

25/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Sugammadex in pregnant women

Scientific title

Pharmacokinetic profile and breastmilk excretion of sugammadex in pregnant women

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy

Anaesthesia

Condition category

Condition code

Anaesthesiology

Anaesthetics

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Hours

Description of intervention(s) / exposure

An open-labelled plasma pharmacokinetic study examining the pharmacokinetics of a single bolus intravenous (IV) dose of sugammadex in women undergoing elective caesarean section under general anaesthesia at the Royal Brisbane and Women’s Hospital (RBWH). We will also determine the amount excreted in breastmilk.

Dosing of sugammadex will be as per manufacturers instructions and determined by train-of four assessment. At the completion of surgery, sugammadex will be administered for reversal at doses determined by the depth of neuromuscular block and according to the product information: 2 mg kg-1 for moderate neuromuscular block (defined by the appearance of two twitches on train of four) and 4 mg kg-1 for deep neuromuscular block (defined as the appearance of two twitches with post-tetanic count) dosed for total body weight. Following administration of sugammadex, a train of four ratio (TOFR) will be performed at 20 second intervals until a TOFR of >0.9 is observed. Sugammadex will be administered at the completion of surgery as per standard practice. A dedicated research nurse who will be present to facilitate sampling and to answer questions about the research and monitor adherence to the intervention.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Measurement of plasma sugammadex levels following administration

Timepoint [1]

Sugammadex plasma concentration from time of bolus to 24 hours post sugammadex administration. A baseline blood sample (t = 0 minutes) will be obtained prior to induction of anaesthesia and at 5, 10, 15, 20, 30, 60 minutes after dosing with sugammadex. A further sample will be taken at 6 hours post sugammadex administration with a final sample at 24 hours that will be taken during routine post caesarean section phlebotomy on day one post-operatively.

Secondary outcome [1]

Measurement of sugammadex concentration in breastmilk following administation.

Timepoint [1]

A sample of breast milk (0.2-0.4 mL) in a sterile syringe in the post anaesthetic care unit one hour following sugammadex administration. A further 0.2-0.4 mL sample of breast milk will be collected at six hours post-operatively.

Secondary outcome [2]

Urine clearance of sugammadex

Timepoint [2]

Urine will be collected via the indwelling catheter from the time of sugammadex administration until 6 hours post sugammadex dose.

Eligibility

Key inclusion criteria

Pregnant women aged greater than or equal to 18 years and less than or equal to 50 years
Scheduled for elective caesarean section under general anaesthesia
Informed consent by patient to participate in study and to store specimens for immediate and future analysis.

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

¦ Known or suspected allergy to sugammadex (urticaria, anaphylaxis, other systemic consequences)
¦ Known or suspected allergy to rocuronium
¦ Renal impairment – serum creatinine > 70 µmol.L-1
¦ Patients with fulminant hepatic failure – confirmed by the presence of hepatic encephalopathy, coagulopathy in the presence of liver enzyme derangement or profound hypoglycaemia
¦ Patients receiving fusidic acid, toremifene and/or flucloxacillin, as these drugs have the potential to displace rocuronium from the sugammadex/rocuronium complex

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Plasma levels of sugammadex and rocuronium will be measured for each sample time point. Individual concentration-time curves for sugammadex will be created for each participant. The intended sample size is 15 participants. Population pharmacokinetic models will be developed from the samples obtained from the 15 individuals and from the collected data, using the modelling software PMetrics®. The pharmacometrics team at the UQ Centre for Clinical Research, will perform regression analysis to statistically validate these models, which can then be used to perform Monte Carlo dosing simulations with PMetrics®, which essentially creates a simulated patient population of 1000 patients based on the different pharmacokinetics in the included patients, to determine whether current dosing regimens achieve adequate drug concentrations, or which optimised dosing regimens should be trialled for efficacy in future studies.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/12/2021

Actual

Date of last participant enrolment

Anticipated

1/06/2023

Actual

Date of last data collection

Anticipated

2/06/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Brisbane and Women's Hospital (Department of Anaesthesia and Perioperative Medicine)

Address [1]

Department of Anaesthesia and Perioperative Medicine Level 4, Ned Hanlon Building Royal Brisbane and Women's Hospital Butterfield Street, Herston, QLD 4029

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Anthony Hodge

Address

Department of Anaesthesia and Perioperative Medicine
Level 4, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD 4029

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 2, Building 34
Royal Brisbane & Women’s Hospital 
Butterfield Street, Herston Qld 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/07/2021

Ethics approval number [1]

HREC/2021/QRBW/74517

Summary

Brief summary

We aim to assess the impact of pregnancy on the pharmacokinetics of sugammadex for reversal from rocuronium-induced neuromuscular blockade in patients undergoing caesarean delivery under general anaesthesia. 
Hypothesis: We hypothesise that the pharmacokinetic parameters of sugammadex (absorption, distribution, and metabolism) are different in pregnant women compared with those in non-pregnant patients. 
Methods: This is an observational open-labelled plasma pharmacokinetic study examining the perioperative pharmacokinetics of a single bolus intravenous (IV) dose of sugammadex in women undergoing elective caesarean delivery under general anaesthesia at the Royal Brisbane and Women’s Hospital (RBWH).

Trial website

Trial related presentations / publications

Public notes

Objectives:
1.	To describe the population pharmacokinetics of sugammadex in obstetric patients.
2.	To perform Monte Carlo dosing simulations using the population model to define optimized dosing regimens for sugammadex in obstetric patients.
3.	To utilize the results to implement guidelines for the dosing of sugammadex in patients presenting for caesarean delivery under general anaesthesia.
4.    To determine the amount of sugammadex excreted in breastmilk

Contacts

Principal investigator

Name

Dr Anthony Hodge

Address

Level 4, Ned Hanlon Building Royal Brisbane and Women's Hospital Butterfield Street, Herston, QLD 4029

Country

Australia

Phone

+61 7 36467154

Fax

[email protected]

Contact person for public queries

Name

Anthony Hodge

Address

Level 4, Ned Hanlon Building Royal Brisbane and Women's Hospital Butterfield Street, Herston, QLD 4029

Country

Australia

Phone

+61 7 36467154

Fax

[email protected]

Contact person for scientific queries

Name

Anthony Hodge

Address

Level 4, Ned Hanlon Building Royal Brisbane and Women's Hospital Butterfield Street, Herston, QLD 4029

Country

Australia

Phone

+61 7 36467154

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• All of the individual participant data collected during the trial, after de-identification will be shared

What types of analyses could be done with individual participant data?

• Any purpose

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication
No end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Attachment
12724	Study protocol	Study-related document.docx
12725	Informed consent form	Study-related document.docx
12726	Ethical approval	Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically