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

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ClinicalTrials.gov Identifier: NCT02797860
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Pregnancy Drug: Rocuronium

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Onset and Duration of Rocuronium Induced Neuromuscular Block Between 2nd Trimester Pregnant and Non-pregnant Women
Study Start Date : June 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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
Drug: Rocuronium
comparison of onset time and duration of rocuronium using Train of Four watch

control
women of childbearing age between 20 and 45
Drug: Rocuronium
comparison of onset time and duration of rocuronium using Train of Four watch




Primary Outcome Measures :
  1. onset time of rocuronium [ Time Frame: until T1 of Train of Four watch is suppressed to 0%,assessed up to 5 minutes ]

Secondary Outcome Measures :
  1. duration of rocuronium [ Time Frame: until T1 of Train of Four watch is recovered to 25%,assessed up to 1 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients scheduled for Transabdominal cervicoisthmic cerclage under general anesthesia
Criteria

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

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): NCT02797860


Locations
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Korea, Republic of
Kangnam sacred heart hospital
Seoul, Yeongdeungpo-gu, Korea, Republic of, KS013
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
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Study Director: Eun Mi Choi, MD Hallym University Kangnam Sacred Heart Hospital

Publications of Results:

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Responsible Party: Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02797860     History of Changes
Other Study ID Numbers: KangnamSHH
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital:
Transabdominal cervicoisthmic cerclage
Rocuronium
Pregnant Women

Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs