Sugammadex in pregnant wome

Not Applicable

• Conditions: Pregnancy; Anaesthesia; Anaesthesiology - Anaesthetics; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12621001449820
• Lead Sponsor: Dr Anthony Hodge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-25
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of plasma sugammadex levels following administration[Sugammadex plasma concentration from time of bolus to 24 hours post sugammadex administration. <br>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.<br>]

Secondary Outcome Measures

Name	Time	Method
Measurement of sugammadex concentration in breastmilk following administation.<br>[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. <br>A further 0.2-0.4 mL sample of breast milk will be collected at six hours post-operatively.];Urine clearance of sugammadex[Urine will be collected via the indwelling catheter from the time of sugammadex administration until 6 hours post sugammadex dose.]