Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy

Laparoscopic Surgery Clinical Trial

Official title:

Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109339
• Other study ID #: 20190501
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2019
• Source: Yangzhou University
• Contact: Zhuan Zhang
• Phone: +8615062791355
• Email: zhangzhuanjy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will study the effect of oxytocin on hemodynamics in patients undergoing laparoscopic myomectomy, and how to prevent and manage such hemodynamic changes effectively.It provides a reference for the rational use of oxytocin in clinical practice, which can not only effectively contract the uterus and reduce bleeding, but also reduce the influence on hemodynamics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• General anesthesia for gynecological laparoscopic surgery,ASA I~III

Exclusion Criteria:

• Oxytocin use contraindications

Related Conditions & MeSH terms

• Hemodynamic Monitoring
• Laparoscopic Surgery
• Oxytocin

Intervention

Drug:
• Oxytocin
During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.	Parameters including SBP, DBP, MAP (mmHg) were measured by a Mostcare hemodynamic monitor.	"before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Primary	Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.	HR (beats/min) was measured by a Mostcare hemodynamic monitor.	"before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Primary	Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.	SVV (%) was measured by a Mostcare hemodynamic monitor.	"before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Primary	Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.	SVRI (dynes-sec/cm-5) was measured by a Mostcare hemodynamic monitor.	"before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Primary	Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.	CI (l/min/m2) was measured by a Mostcare hemodynamic monitor.	"before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Primary	Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.	CO (l/min) was measured by a Mostcare hemodynamic monitor.	"before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".