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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] 304921 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 323065 0
Anaesthesia 323587 0
Condition category
Condition code
Anaesthesiology 320644 320644 0 0
Anaesthetics
Reproductive Health and Childbirth 321133 321133 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
24
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] 321316 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328457 0
Measurement of plasma sugammadex levels following administration
Timepoint [1] 328457 0
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] 399084 0
Measurement of sugammadex concentration in breastmilk following administation.
Timepoint [1] 399084 0
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] 400871 0
Urine clearance of sugammadex
Timepoint [2] 400871 0
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?
No
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
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20123 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 34833 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 309300 0
Hospital
Name [1] 309300 0
Royal Brisbane and Women's Hospital (Department of Anaesthesia and Perioperative Medicine)
Country [1] 309300 0
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] 310273 0
None
Name [1] 310273 0
Address [1] 310273 0
Country [1] 310273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309131 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 309131 0
Level 2, Building 34
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 309131 0
Australia
Date submitted for ethics approval [1] 309131 0
Approval date [1] 309131 0
19/07/2021
Ethics approval number [1] 309131 0
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 113090 0
Dr Anthony Hodge
Address 113090 0
Level 4, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD 4029
Country 113090 0
Australia
Phone 113090 0
+61 7 36467154
Fax 113090 0
Email 113090 0
[email protected]
Contact person for public queries
Name 113091 0
Anthony Hodge
Address 113091 0
Level 4, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD 4029
Country 113091 0
Australia
Phone 113091 0
+61 7 36467154
Fax 113091 0
Email 113091 0
[email protected]
Contact person for scientific queries
Name 113092 0
Anthony Hodge
Address 113092 0
Level 4, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD 4029
Country 113092 0
Australia
Phone 113092 0
+61 7 36467154
Fax 113092 0
Email 113092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification will be shared
When will data be available (start and end dates)?
Immediately following publication
No end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12724Study protocol    382508-(Uploaded-30-07-2021-21-40-47)-Study-related document.docx
12725Informed consent form    382508-(Uploaded-30-07-2021-21-41-07)-Study-related document.docx
12726Ethical approval    382508-(Uploaded-30-07-2021-21-41-29)-Study-related document.pdf



Results publications and other study-related documents

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