NCT04060069

Brief Summary

The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
completed

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

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 9, 2019

Last Update Submit

August 15, 2019

Conditions

Fluid Responsiveness

Outcome Measures

Primary Outcomes (2)

  • to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum

    to evaluate reliability of stroke volume variation in evaluating the response to fluid administration

    up to 10 months

  • to evaluate how pulse pressure variation (%) affected during the Trendelenburg position and pneumoperitoneum

    to evaluate reliability of pulse pressure variation in evaluating the response to fluid administration

    up to 10 months

Study Arms (1)

Before pneumoperitoneum

Fluid administration

Other: Ringer Lactate

Interventions

Ringer LactateOTHER

Fluids

Before pneumoperitoneum

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

45 patients over the age of 18 who would undergo elective laparoscopic gynecological surgery and had the ASA (American Society of Anesthesiologists) risk classification I-II were included in the study.

You may qualify if:

  • Age\>18 years old patients
  • Will undergo elective laparoscopic gynecological surgery
  • ASA I-II

You may not qualify if:

  • Obese patients (body mass index\> 30 kg.m2)
  • Patients who had arrhythmia
  • Patients who had cardiac insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 16, 2019

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

August 16, 2019

Record last verified: 2019-08