Comparison of Onset and Duration of Rocuronium Between 2nd Trimester Pregnant and Non-pregnant Women

February 25, 2019 updated by: Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital

Comparison of Onset and Duration of Rocuronium Induced Neuromuscular Block Between 2nd Trimester Pregnant and Non-pregnant Women

Pregnancy is associated with major changes of the body's physiological status and composition.

These changes may modify the pharmacologic and/or pharmacokinetic profile of some drugs. Pharmacodynamic and pharmacokinetic changes in the 1st trimester during pregnancy are attributed to the following factors; Increase in plasma volume, heart rate and cardiac output; decrease in blood pressure due to decrease of systemic resistance and relative decrease of hepatic circulation and the aggravation of hepatic dysfunction. These changes intensify as pregnancy progresses into the 3rd trimester and take their effect on the onset time and duration of muscle relaxants.

Rocuronium and the steroidal non-depolarizing muscle relaxant like vecuronium is mostly excreted with bile by hepatic metabolism and classified as the FDA pregnancy category B, and is widely used in general anesthesia of pregnant women. Previous studies reported onset time of rocuronium is affected by cardiac output, blood circulation time of the whole body, and muscle perfusion. Accordingly, many researches were conducted under the assumption of onset time and duration being affected by physiologic changes during pregnancy. For example, in the research where vecuronium was used as muscle relaxant for pregnant woman undergoing C-sec, onset of vecuronium was significantly shorter than that of the control group and duration was longer. In a study investigating rocuronium used for patients right after delivery, onset time was shorter and duration was longer than that of the control group.

However, previous research mostly focused on the 3rd trimester, while there have been only a few studies of onset time and duration of rocuronium in non-obstetric surgery such as the transabdominal cervicoisthmic cerclage (TCIC) or Mcdonald surgery which are performed under general anesthesia during 2nd trimester. In this research, onset time and duration of rocuronium, which is widely used for general anesthesia in 2nd trimester pregnant females, will be compared with those of patients in the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yeongdeungpo-gu
      • Seoul, Yeongdeungpo-gu, Korea, Republic of, KS013
        • Kangnam Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients scheduled for Transabdominal cervicoisthmic cerclage under general anesthesia

Description

Inclusion Criteria:

  • Patients scheduled for Transabdominal cervicoisthmic cerclage under general anesthesia or patients scheduled for elective open abdominal surgery.
  • The American Society of Anesthesiologists physical status class one or two
  • female between 20 and 45

Exclusion Criteria:

  • Patients with liver disease
  • Patients with kidney disease
  • Patients with Diabetes mellitus or heart disease
  • Patients with asthma or Bronchial hypersensitivity
  • Patients with a drug allergy
  • Patients BMI under 18.5 or over 27

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
transabdominal cervicoisthmic cerclage
Second Stage of Labor pregnant women who are scheduled for transabdominal cervicoisthmic cerclage due to incompetent internal os of cervix
comparison of onset time and duration of rocuronium using Train of Four watch
control
women of childbearing age between 20 and 45
comparison of onset time and duration of rocuronium using Train of Four watch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
onset time of rocuronium
Time Frame: until T1 of Train of Four watch is suppressed to 0%,assessed up to 5 minutes
until T1 of Train of Four watch is suppressed to 0%,assessed up to 5 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of rocuronium
Time Frame: until T1 of Train of Four watch is recovered to 25%,assessed up to 1 hour
until T1 of Train of Four watch is recovered to 25%,assessed up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Eun Mi Choi, MD, Hallym University Kangnam Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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