Sugammadex Administration in Pregnancy

NCT ID: NCT05708469

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-15

Study Completion Date

2023-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sugammadex, Pregnant, Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sakarya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sakarya University Training and Research Hospital

Serdivan, Sakarya, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Varela N, Lobato F. Sugammadex and pregnancy, is it safe? J Clin Anesth. 2015 Mar;27(2):183-4. doi: 10.1016/j.jclinane.2014.11.015. Epub 2014 Dec 13. No abstract available.

Reference Type BACKGROUND
PMID: 25516396 (View on PubMed)

Richardson MG, Raymond BL. Sugammadex Administration in Pregnant Women and in Women of Reproductive Potential: A Narrative Review. Anesth Analg. 2020 Jun;130(6):1628-1637. doi: 10.1213/ANE.0000000000004305.

Reference Type BACKGROUND
PMID: 31283616 (View on PubMed)

Torres SM, Duarte DF, Gloria AS, Reis C, Moreira JF, Cunha S, Gomes LL, Dahlem C. Sugammadex administration in pregnant patients undergoing non-obstetric surgery: a case series. Braz J Anesthesiol. 2022 Jul-Aug;72(4):525-528. doi: 10.1016/j.bjane.2021.07.034. Epub 2021 Aug 16.

Reference Type BACKGROUND
PMID: 34411637 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

sakarya ali eman 001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ephedrine vs Phenylephrine - ECG Changes
NCT01243970 TERMINATED PHASE4