Skip to main content
OpenTrials
Completed

NCT Number: NCT04718714

Effects of Dexmedetomidine vs Propofol in Patients With Intra-abdominal Sepsis

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 1993].The 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 insults[P.Delong et al. 2006],[ Yealy et al. 2014].

the patients who are subjected to abdominal surgery in order to treat the cause surgically,and many of these surgical procedures are lengthy and are at risk for either pre-operatively or post-operatively with steady increase in intra-abdominal pressure(IAP) [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]

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Assiut University

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged18 years old or more and had the criteria of intraabdominal sepsis as evident by quick sofa score of 2 or more and have done intraabdominal surgical procedures

Exclusion criteria

  • children pregnant women Patients who receive neuromascular blockers during the first 48 hours of ICU admission known allergy or contraindication to propofol ,dexemedetomidine or midazolam known or suspected brain death

Treatment and study plan

midazolam

Drug

loading dose intravenous infusion of 0.2 mg/kg over 10 minutes followed by a maintenance dose of 0.02 -0.2 mg /kg/hr. over 24 hours.

Propofol

Drug

loading dose intravenous infusion of one mg/kg over 15 minutes followed by a maintenance dose of 20-80 microgram/kg/min. over 24 hours.

Dexmedetomidine

Drug

loading dose of dexmedetomidine of one µg/kg over 10 minutes followed by maintenance dose of 0.2 -1.5 µg/kg/hr. over 24 hours.

Primary outcomes

  1. interleukin 1 plasma concentration

    Time frame: 48 hours

    interleukin 1 plasma concentration will be measured three times, at admission ,24 hours after admission and 48 hours after admission

  2. interleukin 6 plasma concentration

    Time frame: 48 hours

    interleukin 6 plasma concentration will be measured three times ,at admission ,24 hours after admission and 48 hours after admission

  3. intraabdominal pressure per mmHg

    Time frame: 48 hours

    intraabdominal pressure will be measured three times ,at admission ,24 hours after admission and 48 hours after admission

Secondary outcomes

  1. difference of mean time of ventilator free days

    Time frame: 28 days

    difference of mean time of ventilator free days between the three arms

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effects of Dexmedetomidine vs Propofol on Inflammatory Response and Intra-abdominal Pressure in Patients With Intra-abdominal Sepsis; a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.