Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness

Influence of Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness Predicted by Pulse Pressure Variation and Stroke Volume Variation During Anaesthesia for Laparoscopic Gynaecological Surgery

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.

Study Overview

• Status: Completed
• Conditions: Fluid Responsiveness
• Intervention / Treatment: Other: Ringer Lactate

Detailed Description

After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.

• Study Type: Observational
• Enrollment (Actual): 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before pneumoperitoneum; Fluid administration	Other: Ringer Lactate; Fluids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: KOU GOKAEK 2016/272

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No