NCT04109339

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

August 15, 2019

Last Update Submit

September 26, 2019

Conditions

OxytocinHemodynamic MonitoringLaparoscopic Surgery

Keywords

OxytocinHemodynamicMyomectomy

Outcome Measures

Primary Outcomes (6)

  • 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".

  • 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".

  • 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".

  • 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".

  • 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".

  • 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".

Study Arms (4)

group 1 with no oxytocin

NO INTERVENTION

group 2 with oxytocin 10 U IM + oxytocin 10 U IV

EXPERIMENTAL
Drug: Oxytocin

group 3 with oxytocin 20 U IM + oxytocin 0 U IV

EXPERIMENTAL
Drug: Oxytocin

group 4 with oxytocin 0 U IM + oxytocin 20 U IV

EXPERIMENTAL
Drug: Oxytocin

Interventions

OxytocinDRUG

During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs.

group 2 with oxytocin 10 U IM + oxytocin 10 U IVgroup 3 with oxytocin 20 U IM + oxytocin 0 U IVgroup 4 with oxytocin 0 U IM + oxytocin 20 U IV

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Oxytocin use contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225012, China

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Zhuan Zhang

CONTACT

+8615062791355zhangzhuanjy@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2019

First Posted

September 30, 2019

Study Start

May 1, 2019

Primary Completion

December 31, 2019

Study Completion

October 1, 2020

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

CN(1)