The Effect of Intra-abdominal Pressure

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03931759
• Other study ID #: EBYU1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2019
• Est. completion date: June 2020

Study information

• Verified date: April 2019
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Effect of Intra-abdominal Pressure

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• diabetes mellitus

• laparoscopic surgery

Exclusion Criteria:

• hypertension

• hearth failure

• renal failure

• hepatic failure

• difficult intubation

• shock

Related Conditions & MeSH terms

• ASA Triad
• Cardiac Autonomic Neuropathy
• Diabetes Mellitus
• Nervous System Diseases

Intervention

Diagnostic Test:
• laparoscopic surgery
patients with diabetes mellitus in laparoscopic surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of heart rate variability in laparoscopic surgeries	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.	1 year