Sugammadex Administration in Pregnancy

Completed

• Conditions: Sugammadex, Pregnant, Anesthesia

• Registration Number: NCT05708469
• Lead Sponsor: Sakarya University

Brief Summary

In this study, the investigators aimed to evaluate the maternal and fetal effect of sugammadex in pregnant patients undergoing a non-obstetric surgery. The investigators mainly focused on the short- and long-term adverse effects such as an abortion or a teratogenic effect and that may occur in fetus and the adverse effects that may be seen in mother.

Detailed Description

Since the approval in Europe in 2008, sugammadex has been widely studied among pregnant patients in the context of cesarean deliveries. However, the use of sugammadex in pregnant patients undergoing a non-obstetric surgery is not clearly defined. The package insert indicates that there are no data on its use in pregnant women regarding the drug-associated risks. There are some questions raised, and answers needed from the scientific community about the maternal and fetal effect of sugammadex administered in pregnant patients.

This is a retrospective case-control cohort study which was conducted in a single-center territory university hospital. The investigators used the hospital information management system for determining the patients that are eligible for inclusion. Patients operated between January 2017 and june 2022 were included in the study. Patient data was obtained by manual review of anesthesia charts of eligible patients. Pregnant patients who underwent a non-pregnancy surgical intervention within the study period were included in the study.

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-01
• Study Start: 2023-03-15
• Primary Completion: 2023-06-15
• Study Completion: 2023-08-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Pregnant women who were operated under general anesthesia during pregnancy and who used sugammadex during the awakening phase.

Exclusion Criteria

• Patients with severe hepatic and renal impairment
• Patients with missing data
• Patients with fetal anomaly detected before the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal outcome	one week postoperatively	Determined by using APGAR score.
Preterm labor	Labor that starts before 37 completed weeks of pregnancy	Labor that starts before 37 completed weeks of pregnancy.

Trial Locations

Locations (1)

Sakarya University Training and Research Hospital; 🇹🇷 Serdivan, Sakarya, Turkey