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Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030911
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Dexmedetomidine Midazolam Sedation Drug: Dexmedetomidine Drug: Midazolam Drug: Fentanyl Device: Indirect calorimetry Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients: Randomized Controlled Study
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 10, 2018
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexmedetomidine group
  • Patients will receive analgesia with fentanyl at a fixed dose of 1 µg.kg.hr-1. Each patient will receive the study drug within 24 hours after intubation. Sedatives used before study enrolment will be discontinued 6 hours prior to the initiation of study drug.
  • Group I patients will have dexmedetomidine (0.075 µg.kg-1.mL-1). Dexmedetomidine infusion will be started at 0.15 µg.kg-1.hr-1 (2 mL.hr-1) and will be adjusted by 0.15 µg.kg-1.h-1 increments to a maximum of 0.75 µg/kg/h (10 ml.h-1)
  • Intervention: indirect calorimetry
Drug: Dexmedetomidine
The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
Other Name: Precedex

Drug: Fentanyl
The drug will be administered in both groups

Device: Indirect calorimetry
The device will be used for measurement of basal metabolic rate
Other Name: Calorimetry

Placebo Comparator: midazolam group
  • Patients will receive analgesia with fentanyl at a fixed dose of 1 µg.kg.hr-1. Each patient will receive the study drug within 24 hours after intubation. Sedatives used before study enrolment will be discontinued 6 hours prior to the initiation of study drug.
  • Group II patients will have midazolam (0.5 mg.mL-1). Midazolam will be started at 1 mg.h-1 (2 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (10 mL.h-1). All infusions will be adjusted by increments of 2 mL.hr-1 to maintain blinding. Patients in either group not adequately sedated by the maximum infusion rate of the study medication will receive a bolus dose of fentanyl 0.5 µg.kg-1.
  • Intervention: indirect calorimetry
Drug: Midazolam
The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
Other Name: dormicum

Drug: Fentanyl
The drug will be administered in both groups

Device: Indirect calorimetry
The device will be used for measurement of basal metabolic rate
Other Name: Calorimetry




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030911


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mohamed Abdulatif, Professor Professor and member of research committee of anesthesia department
Publications:
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Responsible Party: Ahmed Hasanin, Lecturer of anesthesia and critical care medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03030911    
Other Study ID Numbers: N-26-2016
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Fentanyl
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents