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Pediatric AnesthesiaPhase 4NCT03384563

Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane

A Phase 4 study testing Dexmedetomidine in people with Pediatric Anesthesia, run by Baylor College of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this protocol is to determine the effect of two clinically applicable Dexmedetomidine dosages (0.5mcg/kg and 1mcg/kg) on the minimum alveolar concentration (MAC) of Sevoflurane in children between the age ranges of: 1-6 months; 6-12 months of age and 12 months-36 months years of age. Read more about this study

Who is it for?
Ages 1 month to 36 monthsHealthy volunteers can take part
Conditions the study is for
Pediatric Anesthesia
What is being tested?
Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteUnited States
Study dates
18 Feb 2018to 31 Dec 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All patients age 1 month- 3 years presenting for surgery.

Who cannot join

  • Interstitial lung disease, chest wall disease, or bronchospastic disease with no flare-ups in the past 2 weeks of presentation
  • History of difficult intubation or ventilation
  • Airway malformation
  • Congenital heart disease
  • Cardiac arrhythmias
  • Central nervous system disease, including developmental delay, cerebral palsy, or seizure disorder
Show all 14Show fewer
  • History of or family history of malignant hyperthermia
  • Electrolyte disorders
  • Gastrointestinal disease
  • Hepatic dysfunction
  • Renal dysfunction
  • Metabolic disease, such as diabetes
  • Obesity, defined as a body mass index greater than the 95% percentile for age
  • Preterm infant (less than 37 weeks gestational age) 15. Use of any medications (anticonvulsants, opioids, benzodiazepines, antibiotics, antihistamines drugs that induce hepatic enzymes) that may affect MAC.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Margaret Owens-Stuberfield contact

832-824-5800

owensstu@bcm.edu

United States1 site, 1 recruiting
  • Texas Children's Hospital

    Houston, Texas, 77030

    Rahul Baijal, 832-824-5800, rbaijal@bcm.edu

    Recruiting

Other trials in United States

About this study

The purpose of this protocol is to determine the effect of two clinically applicable Dexmedetomidine dosages (0.5mcg/kg and 1mcg/kg) on the minimum alveolar concentration (MAC) of Sevoflurane in children between the age ranges of: 1-6 months; 6-12 months of age and 12 months-36 months years of age.

Read the detailed description

The anesthetic potency of an inhalational anesthetic is measured by the minimum alveolar concentration (MAC), or the dose required to suppress movement to a surgical stimulus in 50% of patients. This measure of potency may also be used to assess the effects of other agents on the MAC of the inhalational agent. Sedative agents reduce MAC of inhalational anesthetic agents. Two human adult studies have shown that Dexmetomidine decreased the minimum alveolar concentration of Isoflurane and Sevoflurane. Age has an important effect on the MAC of inhalational anesthetics in children. Sevoflurane is a commonly used polyflourinated methyl ether with a low blood:gas partition coefficient, which facilitates a rapid increase in alveolar and tissue anesthetic partial pressures and subsequent rapid emergence from anesthesia. Additionally, Sevoflurane is non-stimulating to airway reflexes facilitating smooth inhalational induction of anesthesia. The MAC of Sevoflurane is also dependent on age with the MAC in neonates (<28 days) 3.3%, infants between 6-12 months of age 3.2%, and infants 6-12 months of age and children 1-12 years of age 2.5%. MAC is affected by several factors. Hypothermia, hyponatremia, hypo-osmolality, metabolic acidosis, hypoxia, hypercarbia, anemia, pregnancy, nitrous oxide, opioids, propofol, benzodiazepines, and acute alcohol use decrease MAC whereas hyperthermia, cocaine, amphetamines, hypernatremia, chronic alcohol use increase MAC. Dexmetomidine is an alpha-2 agonist that has been used as a premedication, an adjunct to analgesia, and an adjunct to general inhalational anesthesia. Alpha-2 adrenergic agonist additionally decease the stress response to surgery. Alpha-2 adrenergic agonists have sedative, hypnotic, and analgesic properties and have been reported to decrease the amount of other sedative, analgesic, and general inhalational anesthetics in not only animal studies but also human studies. A concentration-response relationship has been reported in adults receiving Dexmedetomidine using the visual analog scale (VAS) sedation scale (0-100) with a 0 as very alert and 100 as very sedated. A score of 40 correlated with a Dexmedetomidine concentration of 0.7mcg/mL and a score of 60 with a plasma concentration of 1.2mcg/mL. The sedated target concentration from a pooled population of children and neonates has been reported to be between 0.4 and 0.8 mcg/mL. Additionally, a plasma concentration of 0.6mcg/mL has been estimated as satisfactory for sedation in the adult ICU. Inhalational anesthetics have been shown to cause neuroapoptosis and neurodegenerative changes in various animal models; however, the human data from retrospective and epidemiologic studies in children exposed to inhalational anesthetics is inconclusive. There are ongoing trials to determine the effect of exposure from inhalational anesthetics on neurodevelopment outcomes. There is emerging evidence that Dexmedetomidine is not associated with neuroapoptosis or other neurodegenerative changes. Dexmedetomidine has actually been shown to attenuate Isoflurane-induced neurocognitive impairment in neonatal rats. There is no information regarding the reduction of MAC of Sevoflurane in children with clinically applicable Dexmetomidine dosing regimens. Additionally, determining the degree of reduction of Sevoflurane MAC by Dexmedetomidine may be helpful in providing an alternative anesthetic regimen such as the routine use of Dexmedetomidine and Sevoflurane in order to decrease the potential neuroapoptotic effects of inhalational anesthetic agents.

Being tested
Dexmedetomidine
Keywords
pediatric, anesthesia, dexmedetomidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03384563
Study groupRoleWhat they receive
Dexmedetomidine 0.5 mcg/kg 1-6 monthsActive comparatorPrecedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Dexmedetomidine 1 mcg/kg 1-6 monthsActive comparatorPrecedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Dexmedetomidine 0.5 mcg/kg 6-12 monthsActive comparatorPrecedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Dexmedetomidine 1 mcg/kg 6-12 monthsActive comparatorPrecedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Placebo 6-12 monthsPlacebo comparatorSaline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Dexmedetomidine 0.5 mcg/kg 1-3 yearsActive comparatorPrecedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Dexmedetomidine 1 mcg/kg 1-3 yearsActive comparatorPrecedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Placebo 1-3 yearsPlacebo comparatorSaline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine
Placebo 1-6 monthsPlacebo comparatorSaline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement

    The study is completed after assessment of patient movement with skin incision

    Measured: Immediately following skin incision

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2017
  2. Study start18 Feb 2018
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03384563
Sponsor's protocol ID
H-37186
Status last verified
Sep 2025
First submitted
19 Dec 2017
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine in people with Pediatric Anesthesia, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Margaret Owens-Stuberfield (832-824-5800, owensstu@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement (time frame: Immediately following skin incision). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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