NCT04253093

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

January 29, 2020

Last Update Submit

January 31, 2020

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • duration of rocuronium

    time measured with TOFwatch-SX

    time measured to 25% recovery with T1 using Train of Four watch, assessed upto 1 hour

Secondary Outcomes (1)

  • onset of rocuronium

    time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

case: late second trimester pregnant women undergoing general anesthesia control: non-pregnant women undergoing general anesthesia

You may qualify if:

  • women undergoing general anesthesia

You may not qualify if:

  • liver disease
  • renal disease
  • diabetes mellitus
  • asthma
  • allergic to specific drugs
  • BMI\>30 or \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam sungshim hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Eunmi Choi

    professor

    STUDY CHAIR

Central Study Contacts

InJung Jun

CONTACT

82-10-9312-0162christine17@hanmail.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 5, 2020

Study Start

August 1, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

KR(1)