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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

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.

Condition or disease
Pregnancy Related

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
case: late second trimester pregnant women undergoing general anesthesia control: non-pregnant women undergoing general anesthesia
Criteria

Inclusion Criteria:

  • women undergoing general anesthesia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253093


Contacts
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Contact: InJung Jun 82-10-9312-0162 christine17@hanmail.net

Locations
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Korea, Republic of
Kangnam sungshim hospital Recruiting
Seoul, Korea, Republic of
Contact: Jun In-Jung         
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
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Study Chair: Eunmi Choi professor
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Responsible Party: Choi Eun MI, professor, Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT04253093    
Other Study ID Numbers: 2019-05-008
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No