The Effect of Intra-abdominal Pressure
1 other identifier
interventional
130
0 countries
N/A
Brief Summary
The Effect of Intra-abdominal Pressure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Jun 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMay 2, 2019
April 1, 2019
1 year
April 23, 2019
April 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Diabetes mellitus
ACTIVE COMPARATORpatients with diabetes mellitus
non-Diabetes mellitus
NO INTERVENTIONpatients without diabetes mellitus
Interventions
patients with diabetes mellitus in laparoscopic surgery
Eligibility Criteria
You may qualify if:
- diabetes mellitus
- laparoscopic surgery
You may not qualify if:
- hypertension
- hearth failure
- renal failure
- hepatic failure
- difficult intubation
- shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research assistant
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 30, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
May 2, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share