Effect of sugammadex on the serum plasma levels of circulating oestrogens and progesterones in healthy females who take hormone contraception in the perioperative setting

Not Applicable

Completed

• Conditions: Hormonal changes; Contraception; Reproductive Health and Childbirth - Contraception; Anaesthesiology - Anaesthetics; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12621000409875
• Lead Sponsor: Dr. Tamblyn Devoy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-15
• Study Completion: 2021-11-23
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

Pre-menopausal females 18-50 years old undergoing a planned procedure

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in free serum oestrogen after administration of sugammadex in the perioperative setting[0 minutes pre-administration of sugammadex (note: can be anytime from the start of the case until receiving sugammadex)<br>15 minutes after sugammadex administration and 240 minutes after sugammadex administration. ];Change in free serum progesterone after administration of sugammadex in the perioperative setting? <br>[0 minutes pre-administration of sugammadex (note: can be anytime from the start of the case until receiving sugammadex)<br>15 minutes after sugammadex administration and 240 minutes after sugammadex administration. ]

Secondary Outcome Measures

Name	Time	Method
What is the natural change in free serum oestrogen levels during a procedure?[0 minutes pre-procedure, 15 minutes after the procedure as defined by time of leaving operating room and 240 minutes after the procedure. ];What is the natural change in free serum progesterone levels during a procedure?[0 minutes pre-procedure, 15 minutes after the procedure as defined by time of leaving operating room and 240 minutes after the procedure. ]