Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy

September 26, 2019 updated by: Zhuan Zhang, Yangzhou University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225012
        • Recruiting
        • the Affiliated Hospital of Yangzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Oxytocin use contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: group 1 with no oxytocin
Experimental: group 2 with oxytocin 10 U IM + oxytocin 10 U IV
Drug: Oxytocin
During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs.
Experimental: group 3 with oxytocin 20 U IM + oxytocin 0 U IV
Drug: Oxytocin
During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs.
Experimental: group 4 with oxytocin 0 U IM + oxytocin 20 U IV
Drug: Oxytocin
During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time Frame: "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".
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".
Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time Frame: "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".
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".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time Frame: "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".
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".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time Frame: "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".
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".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time Frame: "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".
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".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time Frame: "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".
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".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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