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Trial registered on ANZCTR


Registration number
ACTRN12621000409875
Ethics application status
Approved
Date submitted
6/02/2021
Date registered
15/04/2021
Date last updated
23/12/2021
Date data sharing statement initially provided
15/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sugammadex on the serum plasma levels of circulating oestrogens and progesterones in healthy females who take hormone contraception in the perioperative setting
Scientific title
Effect of sugammadex on the serum plasma levels of circulating oestrogens and progesterones in healthy females who take hormone contraception in the perioperative setting
Secondary ID [1] 303373 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormonal changes 320639 0
Contraception 320640 0
Condition category
Condition code
Reproductive Health and Childbirth 318498 318498 0 0
Contraception
Anaesthesiology 318919 318919 0 0
Anaesthetics
Metabolic and Endocrine 318920 318920 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pre-menopausal women between 18-50 years old who are undergoing a planned operative procedure, are on a hormone contraceptive, and receiving 1 dose of IV sugammadex (dose variable based as determined by treating anaesthetist) will have 3 serum samples (time = 0min, 15min, 240min post-sugammadex) taken to assess the change in serum oestrogen and progesterone. Note: time for sugammadex = 0 minutes can be anytime prior to administration of sugammadex. Timing of sugammadex administration is at end of the procedure though timing will vary depending on each case and treating anaesthetist.
The eligibility of participants will be based on a questionnaire if they are likely to receive sugammadex in their procedure. There are no changes to a patient's anaesthetic regimen as determined by their treating anaesthetist (i.e. they would receive sugammadex regardless if participants were enrolled in the study).
Intervention code [1] 320251 0
Not applicable
Comparator / control treatment
Two control groups. 2:1 control:intervention
Control A: pre-menopausal women between 18-50 years old who who are undergoing a planned operative procedure, are not on hormone contraception and are not receiving sugammadex.
Control B: pre-menopausal women between 18-50 years old who who are undergoing a planned operative procedure, are not on hormone contraception and receiving 1 dose of IV sugammadex (dose variable based as determined by treating anaesthetist).
Both control groups will have the same sample times as the intervention group, however, time from sugammadex in the group not receiving sugammadex is define as end of procedure starting when patient leaves the operating room.

The eligibility of participants will be based on a questionnaire. There are no changes to a patient's anaesthetic regimen as determined by their treating anaesthetist (i.e. they would receive sugammadex regardless if participants were enrolled in the study)
Control group
Placebo

Outcomes
Primary outcome [1] 326451 0
Change in free serum oestrogen after administration of sugammadex in the perioperative setting
Timepoint [1] 326451 0
0 minutes pre-administration of sugammadex (note: can be anytime from the start of the case until receiving sugammadex)
15 minutes after sugammadex administration and 240 minutes after sugammadex administration.
Primary outcome [2] 326858 0
Change in free serum progesterone after administration of sugammadex in the perioperative setting?
Timepoint [2] 326858 0
0 minutes pre-administration of sugammadex (note: can be anytime from the start of the case until receiving sugammadex)
15 minutes after sugammadex administration and 240 minutes after sugammadex administration.
Secondary outcome [1] 391531 0
What is the natural change in free serum oestrogen levels during a procedure?
Timepoint [1] 391531 0
0 minutes pre-procedure, 15 minutes after the procedure as defined by time of leaving operating room and 240 minutes after the procedure.
Secondary outcome [2] 404564 0
What is the natural change in free serum progesterone levels during a procedure?
Timepoint [2] 404564 0
0 minutes pre-procedure, 15 minutes after the procedure as defined by time of leaving operating room and 240 minutes after the procedure.

Eligibility
Key inclusion criteria
- Pre-menopausal females 18-50 years old undergoing a planned procedure
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Male participants
- Females <18 years old or >50 years old
- Post-menopausal women
- Incomplete/missing detail in questionnaire form
- Missed oral contraceptive pill in the past week
- New medroxyprogesterone depot given within the last <3 weeks [due to peaked concentration]

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Intervention group:
Sample Size: 60 (36-86)
Sample Size Calculation/Justification: 0.80 power (standard), 0.5 effect size (sugammadex reversal time ~half that of neostigmine – previous gold standard for reversal), Mixed Model ANOVA
Control group: 2:1 control:intervention
Control A: 30 participants
Control B: 30 participants

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/02/2021
Date of last participant enrolment
Anticipated
1/10/2021
Actual
23/11/2021
Date of last data collection
Anticipated
1/10/2021
Actual
23/11/2021
Sample size
Target
120
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18584 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 32958 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 307786 0
Hospital
Name [1] 307786 0
Department of Anaesthetics, The Wollongong Hospital
Country [1] 307786 0
Australia
Primary sponsor type
Individual
Name
Dr. Tamblyn Devoy
Address
Department of Anaesthetics
The Wollongong Hospital
Loftus Street
Wollongong, NSW 2500
Country
Australia
Secondary sponsor category [1] 308495 0
Individual
Name [1] 308495 0
Dr. Natalie Smith
Address [1] 308495 0
Department of Anaesthetics
The Wollongong Hospital
Loftus Street
Wollongong, NSW 2500
Country [1] 308495 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307803 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 307803 0
c/o UOW & ISLHD Health and Medical Human Research Ethics Committee
Northfields Avenue
University of Wollongong
NSW, 2522, Australia
Ethics committee country [1] 307803 0
Australia
Date submitted for ethics approval [1] 307803 0
26/11/2020
Approval date [1] 307803 0
21/01/2021
Ethics approval number [1] 307803 0
2020/ETH03194

Summary
Brief summary
Lab studies suggest that sugammadex can reduce plasma oestrogen and progesterone concentrations to the equivalent effect of 1 missed dose of the pill. However, there has been no investigations of this in real life patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108554 0
Dr Tamblyn Devoy
Address 108554 0
Department of Anaesthetics
The Wollongong Hospital
Loftus Street
Wollongong, NSW 2500
Country 108554 0
Australia
Phone 108554 0
+61400038321
Fax 108554 0
Email 108554 0
[email protected]
Contact person for public queries
Name 108555 0
Tamblyn Devoy
Address 108555 0
Department of Anaesthetics
The Wollongong Hospital
Loftus Street
Wollongong, NSW 2500
Country 108555 0
Australia
Phone 108555 0
+61 2 4222 5000
Fax 108555 0
Email 108555 0
[email protected]
Contact person for scientific queries
Name 108556 0
Tamblyn Devoy
Address 108556 0
Department of Anaesthetics
The Wollongong Hospital
Loftus Street
Wollongong, NSW 2500
Country 108556 0
Australia
Phone 108556 0
+61 2 4222 5000
Fax 108556 0
Email 108556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in patient consent.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10461Ethical approval    381374-(Uploaded-06-02-2021-17-19-51)-Study-related document.pdf
10462Study protocol    381374-(Uploaded-14-08-2021-17-14-02)-Study-related document.docx
10463Informed consent form    381374-(Uploaded-06-02-2021-17-22-37)-Study-related document.docx
14565Ethical approvalAmendment approval.    381374-(Uploaded-14-08-2021-17-12-21)-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
SourceTitleYear of PublicationDOI
Dimensions AIA prospective observational study of the effects of sugammadex on peri-operative oestrogen and progesterone levels in women who take hormonal contraception2022https://doi.org/10.1111/anae.15902
N.B. These documents automatically identified may not have been verified by the study sponsor.