The Effect of Intra-abdominal Pressure

Not Applicable

• Conditions: ASA Triad; Cardiac Autonomic Neuropathy; Diabetes Mellitus
• Interventions: Diagnostic Test: laparoscopic surgery

• Registration Number: NCT03931759
• Lead Sponsor: Erzincan University

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-30
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02
• Study Start: 2019-06
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• diabetes mellitus
• laparoscopic surgery

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diabetes mellitus	laparoscopic surgery	patients with diabetes mellitus

Primary Outcome Measures

Name	Time	Method
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.