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Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women

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ClinicalTrials.gov Identifier: NCT04253093
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital

Tracking Information
First Submitted Date January 29, 2020
First Posted Date February 5, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 31, 2020)
onset of rocuronium [ Time Frame: time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes ]
time measured with TOFwatch-SX
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women
Official Title Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population case: late second trimester pregnant women undergoing general anesthesia control: non-pregnant women undergoing general anesthesia
Condition Pregnancy Related
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 31, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • women undergoing general anesthesia

Exclusion Criteria:

  • liver disease
  • renal disease
  • diabetes mellitus
  • asthma
  • allergic to specific drugs
  • BMI>30 or <18
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: InJung Jun 82-10-9312-0162 christine17@hanmail.net
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04253093
Other Study ID Numbers 2019-05-008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital
Study Sponsor Hallym University Kangnam Sacred Heart Hospital
Collaborators Not Provided
Investigators
Study Chair: Eunmi Choi professor
PRS Account Hallym University Kangnam Sacred Heart Hospital
Verification Date January 2020