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The Effect of Intra-abdominal Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03931759
Recruitment Status : Unknown
Verified April 2019 by Nurhan EREN, Erzincan University.
Recruitment status was:  Not yet recruiting
First Posted : April 30, 2019
Last Update Posted : May 2, 2019
Information provided by (Responsible Party):
Nurhan EREN, Erzincan University

Brief Summary:
The Effect of Intra-abdominal Pressure

Condition or disease Intervention/treatment Phase
Diabetes Mellitus ASA Triad Cardiac Autonomic Neuropathy Diagnostic Test: laparoscopic surgery Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: prospective randomize clinical trial
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Diabetes mellitus
patients with diabetes mellitus
Diagnostic Test: laparoscopic surgery
patients with diabetes mellitus in laparoscopic surgery
Other Name: hearth rate variability

No Intervention: non-Diabetes mellitus
patients without diabetes mellitus

Primary Outcome Measures :
  1. The measurement of heart rate variability in laparoscopic surgeries [ Time Frame: 1 year ]

    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.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diabetes mellitus
  • laparoscopic surgery

Exclusion Criteria:

  • hypertension
  • hearth failure
  • renal failure
  • hepatic failure
  • difficult intubation
  • shock
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Responsible Party: Nurhan EREN, research assistant, Erzincan University Identifier: NCT03931759    
Other Study ID Numbers: EBYU1
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Nurhan EREN, Erzincan University:
diabetes mellitus
cardiac autonomic neuropathy
laparoscopic surgery
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases