Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy

• Sponsor: Yangzhou University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04109339
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 17.1
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxytocin; Hemodynamic Monitoring; Laparoscopic Surgery	Drug: Oxytocin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Oct 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia. ["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.

2. Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia. ["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.

3. Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia. ["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.

4. Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia. ["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.

5. Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia. ["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.

6. Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia. ["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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Oxytocin use contraindications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu	China	225012

Sponsors and Collaborators

• Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhuan Zhang, Principal Investigator, Yangzhou University
• ClinicalTrials.gov Identifier: NCT04109339
• Other Study ID Numbers: 20190501
• First Posted: Sep 30, 2019
• Last Update Posted: Sep 30, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhuan Zhang, Principal Investigator, Yangzhou University: Oxytocin; Hemodynamic; Myomectomy
• Additional relevant MeSH terms: Oxytocin

Study Results

No Results Posted as of Sep 30, 2019