Not Yet RecruitingPhase 4ACTRN12626000073303

SuPro – Sugammadex and its effect on Progestogens

Effect of sugammadex on serum concentrations of levonorgestrel in women who take oral contraceptives – a multicentre randomised control trial (RCT)


Sponsor

ANZCA Foundation

Enrollment

230 participants

Start Date

Feb 2, 2026

Study Type

Interventional

Conditions

Summary

The primary aim of this proposed randomised controlled trial is to determine and compare changes in plasma concentrations of levonorgestrel in women on this drug as part of their oral contraceptive pill after receiving sugammadex or neostigmine.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria4

  • Cis-gender female.
  • Undergoing a surgical procedure requiring anaesthetic that requires paralysis with either vecuronium or rocuronium.
  • On an oral hormonal contraceptive containing levonorgestrel.
  • American Society of Anesthesiologists (ASA) Physical Status Classification System 1-3.

Exclusion Criteria11

  • Cis-gender male.
  • Transgender patients on hormonal compounds.
  • Suspected or confirmed post-menopausal.
  • Confirmed pregnancy on a pre-operative urine pregnancy test.
  • Bilateral oophorectomy.
  • Non-hormonal contraceptive.
  • Hormonal contraceptive that does not contain levonorgestrel.
  • Synthetic hormones are not used for the primary purpose of hormonal contraception (e.g. HRT, treatment of gynaecological conditions, etc.).
  • Missed dose of pill in the past week.
  • Taking an inactive or placebo pill.
  • A history of hypersensitivity to neuromuscular blocking agents or their reversal agents.

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Interventions

Participants assigned to this arm will receive a single dose of 2mg/kg of sugammadex intravenously for neuromuscular reversal at the end of the anaesthetic.

Participants assigned to this arm will receive a single dose of 2mg/kg of sugammadex intravenously for neuromuscular reversal at the end of the anaesthetic.


Locations(3)

Wollongong Hospital - Wollongong

NSW, Australia

St George Hospital - Kogarah

NSW, Australia

Blacktown Hospital - Blacktown

NSW, Australia

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