Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-23 @ 6:49 PM
Study NCT ID:
NCT04718714
Status:
None
Last Update Posted:
2021-04-27 00:00:00
First Post:
2021-01-15 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Dexmedetomidine vs Propofol in Patients With Intra-abdominal Sepsis
Sponsor:
None
Organization:
Study Overview
Official Title:
Effects of Dexmedetomidine vs Propofol on Inflammatory Response and Intra-abdominal Pressure in Patients With Intra-abdominal Sepsis; a Randomized Clinical Trial
Status:
None
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After surgery patients will be transferred to the ICU and will be randomly allocated by use of sealed envelopes ;into one of three groups 20 patients each.
All ICU measurements will be recorded by an observer
The following data will be collected:
* Patients' demographic and clinical data including age, sex, weight ,operative procedure time and type and patient's SOFA score.
* Mean arterial pressure, heart rate (HR), central venous pressure (CVP), and temperature will be continuously monitored . Urine output will be measured hourly and fluid balance will be calculated every 12 hours. All measurements will be obtained at the start of the study (baseline), then at the 24th and 48th hours.
* Lactate, platelets, leukocytes, bilirubin, alanine aminotransferase, and creatinine will be determined at the same times TNF-α, IL-1β, and IL-6 levels will be obtained at baseline, and at the 24th and 48 th hours.
* Intraabdominal pressure and abdominal perfusion pressure will be measured at baseline (15 min before start of the study) and at the 24th and 48th hours per the study protocol.
* Behavioral pain scale, ramsay sedation score and post operative analgesics requirements as a rescue analgesia.
* Duration of mechanical ventilation and length of ICU stay.
All ICU measurements will be recorded by an observer
The following data will be collected:
* Patients' demographic and clinical data including age, sex, weight ,operative procedure time and type and patient's SOFA score.
* Mean arterial pressure, heart rate (HR), central venous pressure (CVP), and temperature will be continuously monitored . Urine output will be measured hourly and fluid balance will be calculated every 12 hours. All measurements will be obtained at the start of the study (baseline), then at the 24th and 48th hours.
* Lactate, platelets, leukocytes, bilirubin, alanine aminotransferase, and creatinine will be determined at the same times TNF-α, IL-1β, and IL-6 levels will be obtained at baseline, and at the 24th and 48 th hours.
* Intraabdominal pressure and abdominal perfusion pressure will be measured at baseline (15 min before start of the study) and at the 24th and 48th hours per the study protocol.
* Behavioral pain scale, ramsay sedation score and post operative analgesics requirements as a rescue analgesia.
* Duration of mechanical ventilation and length of ICU stay.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: