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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797860
• Other study ID #: KangnamSHH
• Status: Completed
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2019
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kangnam sacred heart hospital	Seoul	Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (15)

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. — View Citation

Bernstein IM, Ziegler W, Badger GJ. Plasma volume expansion in early pregnancy. Obstet Gynecol. 2001 May;97(5 Pt 1):669-72. — View Citation

Camp CE, Tessem J, Adenwala J, Joyce TH 3rd. Vecuronium and prolonged neuromuscular blockade in postpartum patients. Anesthesiology. 1987 Dec;67(6):1006-8. — View Citation

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. — View Citation

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. — View Citation

Esbjörner E, Järnerot G, Sandström B, Ostling G. Serum albumin reserve for bilirubin binding during pregnancy in healthy women. Obstet Gynecol. 1989 Jan;73(1):93-6. — View Citation

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. — View Citation

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. — View Citation

Muñoz HR, González AG, Dagnino JA, González JA, Pérez AE. The effect of ephedrine on the onset time of rocuronium. Anesth Analg. 1997 Aug;85(2):437-40. — View Citation

Pühringer 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Anesth Analg 2000 Oct;91(4):833. — View Citation

Van Thiel DH, Gavaler JS. Pregnancy-associated sex steroids and their effects on the liver. Semin Liver Dis. 1987 Feb;7(1):1-7. — View Citation

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. 19 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	onset time of rocuronium		until T1 of Train of Four watch is suppressed to 0%,assessed up to 5 minutes
Secondary	duration of rocuronium		until T1 of Train of Four watch is recovered to 25%,assessed up to 1 hour