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The Effect of Intra-abdominal Pressure

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Nurhan EREN, Erzincan University

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date May 2, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intra-abdominal Pressure
Official Title  ICMJE The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
Brief Summary The Effect of Intra-abdominal Pressure
Detailed Description The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
prospective randomize clinical trial
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Diabetes Mellitus
  • ASA Triad
  • Cardiac Autonomic Neuropathy
Intervention  ICMJE Diagnostic Test: laparoscopic surgery
patients with diabetes mellitus in laparoscopic surgery
Other Name: hearth rate variability
Study Arms  ICMJE
  • Active Comparator: Diabetes mellitus
    patients with diabetes mellitus
    Intervention: Diagnostic Test: laparoscopic surgery
  • No Intervention: non-Diabetes mellitus
    patients without diabetes mellitus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diabetes mellitus
  • laparoscopic surgery

Exclusion Criteria:

  • hypertension
  • hearth failure
  • renal failure
  • hepatic failure
  • difficult intubation
  • shock
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931759
Other Study ID Numbers  ICMJE EBYU1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nurhan EREN, Erzincan University
Study Sponsor  ICMJE Erzincan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Erzincan University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP