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PregnancyNCT02797860

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

An observational study of Pregnancy, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Rocuronium
How many people
90 participants
Where
1 siteSouth Korea
Study dates
Jun 2016to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Patients scheduled for Transabdominal cervicoisthmic cerclage under general anesthesia

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kangnam sacred heart hospital

    Seoul, Yeongdeungpo-gu, KS013

Other trials in South Korea

About this study

Official title: 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.

Read more

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
Being tested
Rocuronium
Keywords
Transabdominal cervicoisthmic cerclage, Rocuronium, Pregnant Women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocuroniumDrug

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

Study groups in NCT02797860
Study groupRoleWhat they receive
transabdominal cervicoisthmic cerclageSecond Stage of Labor pregnant women who are scheduled for transabdominal cervicoisthmic cerclage due to incompetent internal os of cervix
Receives: Drug: Rocuronium
controlwomen of childbearing age between 20 and 45
Receives: Drug: Rocuronium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. onset time of rocuronium

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

Secondary outcomes (1)

  1. duration of rocuronium

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02797860
Sponsor's protocol ID
KangnamSHH
Status last verified
Feb 2019
First submitted
24 May 2016
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Robson SC, Hunter S, Boys RJ, Dunlop W. Serial study of factors influencing changes in cardiac output during human pregnancy. Am J Physiol. 1989 Apr;256(4 Pt 2):H1060-5. doi: 10.1152/ajpheart.1989.256.4.H1060.

    PubMed 2705548

  • Capeless EL, Clapp JF. When do cardiovascular parameters return to their preconception values? Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):883-6. doi: 10.1016/0002-9378(91)90432-q.

    PubMed 1951547

  • Greiss FC Jr, Anderson SG. Effect of ovarian hormones on the uterine vascular bed. Am J Obstet Gynecol. 1970 Jul 15;107(6):829-36. doi: 10.1016/s0002-9378(16)34033-9. No abstract available.

    PubMed 5429013

  • Chapman AB, Abraham WT, Zamudio S, Coffin C, Merouani A, Young D, Johnson A, Osorio F, Goldberg C, Moore LG, Dahms T, Schrier RW. Temporal relationships between hormonal and hemodynamic changes in early human pregnancy. Kidney Int. 1998 Dec;54(6):2056-63. doi: 10.1046/j.1523-1755.1998.00217.x.

    PubMed 9853271

  • Bernstein IM, Ziegler W, Badger GJ. Plasma volume expansion in early pregnancy. Obstet Gynecol. 2001 May;97(5 Pt 1):669-72. doi: 10.1016/s0029-7844(00)01222-9.

    PubMed 11339913

  • Van Thiel DH, Gavaler JS. Pregnancy-associated sex steroids and their effects on the liver. Semin Liver Dis. 1987 Feb;7(1):1-7. doi: 10.1055/s-2008-1040558. No abstract available.

    PubMed 3589711

  • Esbjorner E, Jarnerot G, Sandstrom B, Ostling G. Serum albumin reserve for bilirubin binding during pregnancy in healthy women. Obstet Gynecol. 1989 Jan;73(1):93-6.

    PubMed 2909046

  • Wierda JM, Kleef UW, Lambalk LM, Kloppenburg WD, Agoston S. The pharmacodynamics and pharmacokinetics of Org 9426, a new non-depolarizing neuromuscular blocking agent, in patients anaesthetized with nitrous oxide, halothane and fentanyl. Can J Anaesth. 1991 May;38(4 Pt 1):430-5. doi: 10.1007/BF03007578.

    PubMed 1829656

  • Munoz HR, Gonzalez AG, Dagnino JA, Gonzalez JA, Perez AE. The effect of ephedrine on the onset time of rocuronium. Anesth Analg. 1997 Aug;85(2):437-40. doi: 10.1097/00000539-199708000-00034. No abstract available.

    PubMed 9249127

  • Szmuk P, Ezri T, Chelly JE, Katz J. The onset time of rocuronium is slowed by esmolol and accelerated by ephedrine. Anesth Analg. 2000 May;90(5):1217-9. doi: 10.1097/00000539-200005000-00041.

    PubMed 10781483

  • Hans P, Brichant JF, Hubert B, Dewandre PY, Lamy M. Influence of induction of anaesthesia on intubating conditions one minute after rocuronium administration: comparison of ketamine and thiopentone. Anaesthesia. 1999 Mar;54(3):276-9. doi: 10.1046/j.1365-2044.1999.00703.x.

    PubMed 10364866

  • Baraka A, Jabbour S, Tabboush Z, Sibai A, Bijjani A, Karam K. Onset of vecuronium neuromuscular block is more rapid in patients undergoing caesarean section. Can J Anaesth. 1992 Feb;39(2):135-8. doi: 10.1007/BF03008643.

    PubMed 1347489

  • Camp CE, Tessem J, Adenwala J, Joyce TH 3rd. Vecuronium and prolonged neuromuscular blockade in postpartum patients. Anesthesiology. 1987 Dec;67(6):1006-8. doi: 10.1097/00000542-198712000-00028. No abstract available.

    PubMed 2891326

  • 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.

    PubMed 24724444

  • Puhringer FK, Sparr HJ, Mitterschiffthaler G, Agoston S, Benzer A. Extended duration of action of rocuronium in postpartum patients. Anesth Analg. 1997 Feb;84(2):352-4. doi: 10.1097/00000539-199702000-00020.

    PubMed 9024027

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

onset time of rocuronium (time frame: until T1 of Train of Four watch is suppressed to 0%,assessed up to 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02797860, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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