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

NCT02797860 | Completed

• 1 other identifier: KangnamSHH
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Transabdominal cervicoisthmic cerclage; Rocuronium; Pregnant Women

Outcome Measures

Primary Outcomes (1)

• onset time of rocuronium

  until T1 of Train of Four watch is suppressed to 0%,assessed up to 5 minutes

Secondary Outcomes (1)

• duration of rocuronium

  until T1 of Train of Four watch is recovered to 25%,assessed up to 1 hour

Study Arms (2)

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

control

women of childbearing age between 20 and 45

Drug: Rocuronium

Interventions

Rocuronium DRUG

comparison of onset time and duration of rocuronium using Train of Four watch

control; transabdominal cervicoisthmic cerclage

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for Transabdominal cervicoisthmic cerclage under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, KS013, South Korea

Location

Related Publications (15)

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  PMID: 11339913 RESULT

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  PMID: 3589711 RESULT

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  PMID: 2909046 RESULT

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  PMID: 10781483 RESULT

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  PMID: 10364866 RESULT

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• Sakurai Y, Uchida M, Aiba J, Mimura F, Yamaguchi M, Kakumoto M. [Effects of pregnancy on the onset time of rocuronium]. Masui. 2014 Mar;63(3):324-7. Japanese.

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  PMID: 9024027 RESULT

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Eun Mi Choi, MD

  Hallym University Kangnam Sacred Heart Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hallym University Kangnam Sacred Heart Hospital

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)