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NCT Number: NCT03030911

Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

The aim of this study is to compare the effect of dexmedetomidine on resting energy expenditure in relation to the midazolam in critically ill patients using indirect calorimetry

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

Caloric needs in critically-ill patients fluctuate significantly over the course of the disease which might expose patients to either malnutrition or overfeeding. Malnutrition is associated with deterioration of lean body mass, poor wound healing, increased risk of nosocomial infection, and weakened respiratory muscles. On the other hand overfeeding in medically compromised patients can promote lipogenesis, hyperglycemia, and exacerbation of respiratory failure. Many factors may affect the resting energy expenditure (REE) through manipulation of oxygen consumption (VO2).

Sedatives are important contributors to reduction of REE. The postulated mechanism of sedative-induced reduction of VO2 is inhibition of circulating catecholamine and pro-inflammatory cytokines.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist. Stimulation of the α2-adrenoceptor in the central nervous system causes a 60-80% reduction in sympathetic outflow and endogenous catecholamine levels. It was found that perioperative use of α2 agonists decreased sympathetic activity with subsequent reduction of VO2 and REE. Moreover, dexmedetomidine, has some anti-inflammatory effect by inhibiting the pro-inflammatory cytokines which may cause additional reduction of REE in critically ill patient.

Midazolam is another important sedative that is frequently used in critically-ill patient. Terao et al. found that increasing the depth of sedation using midazolam, decreased oxygen consumption and REE. However, it remains unclear whether the effect of midazolam on REE is related to the drug itself or to the depth of sedation.

There is no direct comparison in the literature between dexmedetomidine and midazolam on REE.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The study will be designed to recruit 30 critically-ill patients who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for 2 days or longer.

Exclusion criteria

  • Age < 18 years old.
  • Pregnant patient.
  • Serious central nervous system pathologies (traumatic brain injury, acute stroke, uncontrolled seizures).
  • Patient who will require fraction of inspired oxygen more than 0.6.
  • Air leak from the chest tube.
  • Patient with body temperature > 39 Celsius.
  • Acute hepatitis or severe liver disease (Child-Pugh class C).
  • Left ventricular ejection fraction less than 30%.
  • Heart rate less than 50 beats/min.
  • Second or third degree heart block.
  • Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors.
  • Patients with known endocrine dysfunction.
  • Patient with hypothermia
  • Patient on Positive end expiratory pressure more than 14 cmH2o

Treatment and study plan

Dexmedetomidine

Drug

The drug will be administered for sedation and its effect on basal metabolic rate will be investigated

Other names: Precedex

midazolam

Drug

The drug will be administered for sedation and its effect on basal metabolic rate will be investigated

Other names: dormicum

Fentanyl

Drug

The drug will be administered in both groups

Indirect calorimetry

Device

The device will be used for measurement of basal metabolic rate

Other names: Calorimetry

Primary outcomes

  1. Change in Resting energy expenditure after drug administration

    Time frame: The first baseline measurement will be taken before drug administration. The second measurement will be taken 24 hours after drug infusion.

    Resting energy expenditure will be measured using indirect calorimetry via metabolic module on General Electric ventilator

Secondary outcomes

  1. Heart rate

    Time frame: 24 hours

    number of heart beats per minute

  2. arterial blood pressure

    Time frame: 24 hours

    arterial blood pressure measured in mmHg

  3. Richmond agitation and sedation scale

    Time frame: 24 hours

    range from -5 (unarousable) to +4 (combative)

  4. Plasma interleukin-1β level

    Time frame: 24 hours

    determined by ELISA using a quantitative sandwich enzyme immunoassay technique

  5. Tumor necrosis factor-α plasma concentration

    Time frame: 24 hours

    Enzyme immunoassay

  6. partial pressure of oxygen in arterial blood

    Time frame: 24 hours

    the partial pressure of oxygen in arterial blood measured in mmHg

  7. VO2

    Time frame: 24 hours

    the oxygen consumption measured in mL/Kg/min

  8. VCO2

    Time frame: 24 hours

    carbon dioxide production measured in mL/Kg/min

  9. end-tidal co2

    Time frame: 24 hours

    the pressure of carbon dioxide in expired air measured in mmHg

  10. cardiac output

    Time frame: 24 hours

    the amount of blood pumped by the heart during one minute

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients: Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2017
Registry last updated
Mar 27, 2018

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.

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