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The Effect of Intra-abdominal Pressure

Sponsor
Erzincan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03931759
Collaborator
(none)
130
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The Effect of Intra-abdominal Pressure

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: laparoscopic surgery
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
prospective randomize clinical trialprospective 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
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. The measurement of heart rate variability in laparoscopic surgeries [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Erzincan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nurhan EREN, research assistant, Erzincan University
    ClinicalTrials.gov Identifier:
    NCT03931759
    Other Study ID Numbers:
    • EBYU1
    First Posted:
    Apr 30, 2019
    Last Update Posted:
    May 2, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, research assistant, Erzincan University
    diabetes mellitus
    cardiac autonomic neuropathy
    laparoscopic surgery
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of May 2, 2019