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Sugammadex in pregnant women

Pharmacokinetic profile and breastmilk excretion of sugammadex in pregnant women

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001449820
Enrollment
10
Registered
2021-10-25
Start date
2022-09-27
Completion date
2024-09-05
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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 d

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.

Sponsors

Dr Anthony Hodge
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026