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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

The Effect of Intra-abdominal Pressure

Clinicaltrials.gov identifier NCT03931759

Recruitment Status Not yet recruiting

First Posted April 30, 2019

Last update posted May 2, 2019

Study Description

Brief summary:

The Effect of Intra-abdominal Pressure

  • Condition or Disease:Cardiac Autonomic Neuropathy
    Diabetes Mellitus
    ASA Triad
  • Intervention/Treatment: Diagnostic Test: laparoscopic surgery
  • Phase: 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
  • 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
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
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- diabetes mellitus

- laparoscopic surgery

Exclusion Criteria:

- hypertension

- hearth failure

- renal failure

- hepatic failure

- difficult intubation

- shock

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Erzincan University

More Information
  • Responsible Party: Erzincan University
  • ClinicalTrials.gov Identifier: NCT03931759 History of Changes
  • 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
  • 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.: Yes
  • Keywords provided by Erzincan University: diabetes mellitus
    cardiac autonomic neuropathy
    laparoscopic surgery
  • Additional relevant MeSH terms: Diabetes Mellitus