Sugammadex, Pregnant, AnesthesiaNCT05708469
Sugammadex Administration in Pregnancy
An observational study of Sugammadex, Pregnant, Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sugammadex, Pregnant, Anesthesia
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women who were operated under general anesthesia during pregnancy and used sugammadex during the recovery period will be included in the study. The study was planned retrospectively. We determined the age group as 18-45.
Who may be able to join
- Pregnant women who were operated under general anesthesia during pregnancy and who used sugammadex during the awakening phase.
Who cannot join
- Patients with severe hepatic and renal impairment
- Patients with missing data
- Patients with fetal anomaly detected before the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Serdivan, Sakarya, 54100
About this study
Official title: Maternal and Fetal Outcomes of Sugammadex Administration During Pregnancy: A Retrospective Cohort Study
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.
Read the 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.
- Conditions
- Sugammadex, Pregnant, Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal outcome
Determined by using APGAR score.
Measured: one week postoperatively
Preterm labor
Labor that starts before 37 completed weeks of pregnancy.
Measured: Labor that starts before 37 completed weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start15 Mar 2023
- Primary completion15 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sugammadex, Pregnant, AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708469
- Sponsor's protocol ID
- sakarya ali eman 001
- Status last verified
- May 2024
- First submitted
- 22 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25516396Richardson 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.
PubMed 31283616Torres 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.
PubMed 34411637
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Fetal Outcomes of Sugammadex Administration During Pregnancy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05708469
- Acronym / sponsor ID
- sakarya ali eman 001
- Conditions
- Sugammadex, Pregnant, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who were operated under general anesthesia during pregnancy and used sugammadex during the recovery period will be included in the study. The study was planned retrospectively. We determined the age group as 18-45.
Key inclusion criteria (1 listed)
- Pregnant women who were operated under general anesthesia during pregnancy and who used sugammadex during the awakening phase.
Key exclusion criteria (3 listed)
- Patients with severe hepatic and renal impairment
- Patients with missing data
- Patients with fetal anomaly detected before the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal outcome
Time frame: one week postoperatively
Determined by using APGAR score.
Preterm labor
Time frame: Labor that starts before 37 completed weeks of pregnancy
Labor that starts before 37 completed weeks of pregnancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 25516396Varela 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.
- Background: PubMed 31283616Richardson 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.
- Background: PubMed 34411637Torres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sugammadex, Pregnant, Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal outcome (time frame: one week postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708469, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.