The Effect of Intra-abdominal Pressure

The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics

The Effect of Intra-abdominal Pressure

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Cardiac Autonomic Neuropathy; ASA Triad
• Intervention / Treatment: Diagnostic test: laparoscopic surgery

Detailed Description

The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diabetes mellitus
• laparoscopic surgery

Exclusion Criteria:

• hypertension
• hearth failure
• renal failure
• hepatic failure
• difficult intubation
• shock

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diabetes mellitus; patients with diabetes mellitus	Diagnostic test: laparoscopic surgery; patients with diabetes mellitus in laparoscopic surgery; Other Names: hearth rate variability
No Intervention: non-Diabetes mellitus; patients without diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measurement of heart rate variability in laparoscopic surgeries	The measurement of heart rate variability is used as a method to assess the autonomic nerve system. As the autonomic nerve system dysfunction may complicate the possible peroperative problems in the patients to be operated, the pre-assessment of the autonomic nerve system function should be considered as an acquisition required to be obtained in the daily anesthesia practice. When we increase the intraabdominal pressure during the laparoscopic surgery, we think that the hemodynamic responses of the diabetic patient group, especially the patients with autonomic neuropathy, to this increasing intraabdominal pressure will be different. The aim of the present study is to investigate the effect of the intraabdominal pressure, applied to the patients diagnosed with diabetes mellitus who will have laparoscopic surgery, on hemodynamics.	1 year

Collaborators and Investigators

• Sponsor: Erzincan University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopic surgery; diabetes mellitus; cardiac autonomic neuropathy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: EBYU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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