Pregnancy RelatedNCT04253093
Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women
An observational study of Pregnancy Related, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The present study is to compare the onset and duration of rocuronium in late second trimester women and non-pregnant women undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pregnancy Related
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 1 Dec 2020
- How long will I take part?
- 1 Day
- 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 20 to 45 years
- Women only
- Adult
Study population: case: late second trimester pregnant women undergoing general anesthesia control: non-pregnant women undergoing general anesthesia
Who may be able to join
- women undergoing general anesthesia
Who cannot join
- liver disease
- renal disease
- diabetes mellitus
- asthma
- allergic to specific drugs
- BMI>30 or <18
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangnam sungshim hospital
Seoul
Jun In-Jung
About this study
The present study is to compare the onset and duration of rocuronium in late second trimester women and non-pregnant women undergoing general anesthesia.
Read the detailed description
Pregnancy induces physiological changes. Plasma volume, cardiac output, hepatic blood flow and protein binding are changed from the first trimester of pregnancy. These physiological changes give effect to the onset and duration of neuromuscular blocking drugs.
Rocuronium is a commonly used neuromuscular blocking drug categorized as FDA category B. Rocuronium is widely used for pregnant women. Previous studies have evaluated the onset and duration of rocuronium in postpartum women. Lately, the investigators have evaluated the onset and duration of rocuronium in early second trimester pregnant women and the duration was significantly longer in early second trimester women compared to non-pregnant women.
Since there is little research on the onset and duration of rocuronium in the late second trimester pregnant women, the investigators planned the present research.
- Conditions
- Pregnancy Related
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of rocuronium
time measured with TOFwatch-SX
Measured: time measured to 25% recovery with T1 using Train of Four watch, assessed upto 1 hour
Secondary outcomes (1)
onset of rocuronium
time measured with TOFwatch-SX
Measured: time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Aug 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Eunmi Choi, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253093
- Sponsor's protocol ID
- 2019-05-008
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women
- ClinicalTrials.gov ID
- NCT04253093
- Acronym / sponsor ID
- 2019-05-008
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
The present study is to compare the onset and duration of rocuronium in late second trimester women and non-pregnant women undergoing general anesthesia.
Detailed description
Pregnancy induces physiological changes. Plasma volume, cardiac output, hepatic blood flow and protein binding are changed from the first trimester of pregnancy. These physiological changes give effect to the onset and duration of neuromuscular blocking drugs.
Rocuronium is a commonly used neuromuscular blocking drug categorized as FDA category B. Rocuronium is widely used for pregnant women. Previous studies have evaluated the onset and duration of rocuronium in postpartum women. Lately, the investigators have evaluated the onset and duration of rocuronium in early second trimester pregnant women and the duration was significantly longer in early second trimester women compared to non-pregnant women.
Since there is little research on the onset and duration of rocuronium in the late second trimester pregnant women, the investigators planned the present research.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- case: late second trimester pregnant women undergoing general anesthesia control: non-pregnant women undergoing general anesthesia
Key inclusion criteria (1 listed)
- women undergoing general anesthesia
Key exclusion criteria (6 listed)
- liver disease
- renal disease
- diabetes mellitus
- asthma
- allergic to specific drugs
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
duration of rocuronium
Time frame: time measured to 25% recovery with T1 using Train of Four watch, assessed upto 1 hour
time measured with TOFwatch-SX
1 secondary outcome
onset of rocuronium
Time frame: time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
Eunmi Choi study chair
professor
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 Pregnancy Related, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact InJung Jun (82-10-9312-0162, christine17@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of rocuronium (time frame: time measured to 25% recovery with T1 using Train of Four watch, assessed upto 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.