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

The present study is to compare the onset and duration of rocuronium in late second trimester women and non-pregnant women undergoing general anesthesia.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: InJung Jun; Phone Number: 82-10-9312-0162; Email: christine17@hanmail.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangnam Sungshim Hospital
    • Contact: Jun In-Jung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

Inclusion Criteria:

• women undergoing general anesthesia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
onset of rocuronium	time measured with TOFwatch-SX	time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Study Chair: Eunmi Choi, Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-05-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No