The Effect of Intra-abdominal Pressure
The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diabetes mellitus
- laparoscopic surgery
Exclusion Criteria:
- hypertension
- hearth failure
- renal failure
- hepatic failure
- difficult intubation
- shock
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Diabetes mellitus
patients with diabetes mellitus
|
patients with diabetes mellitus in laparoscopic surgery
Other Names:
|
|
No Intervention: non-Diabetes mellitus
patients without diabetes mellitus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBYU1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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