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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04253093
• Other study ID #: 2019-05-008
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2020
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: InJung Jun
• Phone: 82-10-9312-0162
• Email: christine17[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• women undergoing general anesthesia

Exclusion Criteria:

• liver disease

• renal disease

• diabetes mellitus

• asthma

• allergic to specific drugs

• BMI>30 or <18

Related Conditions & MeSH terms

• Pregnancy Related

Locations

Country	Name	City	State
Korea, Republic of	Kangnam sungshim hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	onset of rocuronium	time measured with TOFwatch-SX	time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes