Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04718714
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2021-01-15
Brief Title:
Effects of Dexmedetomidine vs Propofol in Patients With Intra-abdominal Sepsis
Sponsor:
Assiut University
Organization:
Assiut University
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:
COMPLETED
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:
Sepsis is defined as systemic response to infection and it is a main problem in ICU and despite advance in supportive care the mortality rate in patients with severe sepsis continues to exceed 30 Bone RC 1993The effects of bacterial invasion of body tissues result from combined actions of enzymes and toxins produced by micro-organisms themselves and by a network of proinflammatory mediators and cytokines as tumour necrosis factor α and interleukin 6 which are overexpressed after various noxious insultsPDelong et al 2006 Yealy et al 2014
the patients who are subjected to abdominal surgery in order to treat the cause surgicallyand many of these surgical procedures are lengthy and are at risk for either pre-operatively or post-operatively with steady increase in intra-abdominal pressureIAP Malbrain ML et al 2007 Intra-abdominal hypertension IAH is defined as IAP equal to or greater than 12 mmHg whereas abdominal compartment syndrome ACS is defined as IAP greater than 20 mmHg abdominal perfusing pressure APP is used to predict prognosis of both IAH and ACS Malbrain ML et al 2006
The choice for using a sedative agent in ICU for mechanically ventilated patients post-operatively is therefore a crucial one as these patients are under hyperstress state and often require drugs for sedation and analgesia Chanques G et al 2006
Analgesics and sedation agents have clearly been shown to alter cellular function and other mediators of immune system with wide range of immune modulation ranging from immunosuppressive effects to significant anti-inflammatory effects during endotoxaemia Taniguchi et al 2004 Also sedation and or analgesia have the potential to reduce IAP through improvement of abdominal wall compliance
Although propofol and dexmedetomidine are used for sedation in ICU there are limited data on their effects on inflammatory responses and IAP in septic patients
In clinical practice septic patients treated with dexmedetomidine have shorter time on the ventilator as compared with those treated with lorazepam a benzodiazepine and this beneficial effect of dexmedetomidine is more pronounced in septic patients than in nonseptic patients This outcome may be partly the result of dexmedetomidine induced reduction in pulmonary inflammatory mediators and lung tissue damage M Ueki et al 2014 Midazolam is known to inhibit certain aspects of the immune function It was suggested that benzodiazepines bind to specific receptors on macrophages and inhibit their capacity to produce IL-1 IL-6 and TNFα
Propofol nowadays has become a preferred sedative in ICU because it offers advantages over benzodiazepines in terms of lack of accumulation quick onset easy adjustment and fast recovery after discontinuation Jacobi J et al 2002
the patients who are subjected to abdominal surgery in order to treat the cause surgicallyand many of these surgical procedures are lengthy and are at risk for either pre-operatively or post-operatively with steady increase in intra-abdominal pressureIAP Malbrain ML et al 2007 Intra-abdominal hypertension IAH is defined as IAP equal to or greater than 12 mmHg whereas abdominal compartment syndrome ACS is defined as IAP greater than 20 mmHg abdominal perfusing pressure APP is used to predict prognosis of both IAH and ACS Malbrain ML et al 2006
The choice for using a sedative agent in ICU for mechanically ventilated patients post-operatively is therefore a crucial one as these patients are under hyperstress state and often require drugs for sedation and analgesia Chanques G et al 2006
Analgesics and sedation agents have clearly been shown to alter cellular function and other mediators of immune system with wide range of immune modulation ranging from immunosuppressive effects to significant anti-inflammatory effects during endotoxaemia Taniguchi et al 2004 Also sedation and or analgesia have the potential to reduce IAP through improvement of abdominal wall compliance
Although propofol and dexmedetomidine are used for sedation in ICU there are limited data on their effects on inflammatory responses and IAP in septic patients
In clinical practice septic patients treated with dexmedetomidine have shorter time on the ventilator as compared with those treated with lorazepam a benzodiazepine and this beneficial effect of dexmedetomidine is more pronounced in septic patients than in nonseptic patients This outcome may be partly the result of dexmedetomidine induced reduction in pulmonary inflammatory mediators and lung tissue damage M Ueki et al 2014 Midazolam is known to inhibit certain aspects of the immune function It was suggested that benzodiazepines bind to specific receptors on macrophages and inhibit their capacity to produce IL-1 IL-6 and TNFα
Propofol nowadays has become a preferred sedative in ICU because it offers advantages over benzodiazepines in terms of lack of accumulation quick onset easy adjustment and fast recovery after discontinuation Jacobi J et al 2002
Detailed Description:
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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None