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.
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.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Rahul Baijal, 832-824-5800, rbaijal@bcm.edu
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.
- Conditions
- Pediatric Anesthesia
- 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.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine 9 arms
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0.5 mcg/kg 1-6 months | Active comparator | Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 1 mcg/kg 1-6 months | Active comparator | Precedex 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 months | Active comparator | Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 1 mcg/kg 6-12 months | Active comparator | Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. Receives: Drug: Dexmedetomidine |
| Placebo 6-12 months | Placebo comparator | Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 0.5 mcg/kg 1-3 years | Active comparator | Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 1 mcg/kg 1-3 years | Active comparator | Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. Receives: Drug: Dexmedetomidine |
| Placebo 1-3 years | Placebo comparator | Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. Receives: Drug: Dexmedetomidine |
| Placebo 1-6 months | Placebo comparator | Saline 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.
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.
- First posted27 Dec 2017
- Study start18 Feb 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Baijal, Baylor College of Medicine
- Investigators
- Rahul Baijal, MD, Principal investigator, Baylor College of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
- ClinicalTrials.gov ID
- NCT03384563
- Acronym / sponsor ID
- H-37186
- Conditions
- Pediatric Anesthesia
- Keywords
- pediatric, anesthesia, dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0.5 mcg/kg 1-6 months | Active comparator | Drug: DexmedetomidinePrecedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Dexmedetomidine 1 mcg/kg 1-6 months | Active comparator | Drug: DexmedetomidinePrecedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Dexmedetomidine 0.5 mcg/kg 6-12 months | Active comparator | Drug: DexmedetomidinePrecedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Dexmedetomidine 1 mcg/kg 6-12 months | Active comparator | Drug: DexmedetomidinePrecedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Placebo 6-12 months | Placebo comparator | Drug: DexmedetomidineSaline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Dexmedetomidine 0.5 mcg/kg 1-3 years | Active comparator | Drug: DexmedetomidinePrecedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Dexmedetomidine 1 mcg/kg 1-3 years | Active comparator | Drug: DexmedetomidinePrecedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Placebo 1-3 years | Placebo comparator | Drug: DexmedetomidineSaline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
| Placebo 1-6 months | Placebo comparator | Drug: DexmedetomidineSaline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration. |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients age 1 month- 3 years presenting for surgery.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine 9 arms | Drug | Dexmedetomidine 0.5 mcg/kg 1-3 years, Dexmedetomidine 0.5 mcg/kg 1-6 months, Dexmedetomidine 0.5 mcg/kg 6-12 months, Dexmedetomidine 1 mcg/kg 1-3 years, Dexmedetomidine 1 mcg/kg 1-6 months, Dexmedetomidine 1 mcg/kg 6-12 months, Placebo 1-3 years, Placebo 1-6 months, Placebo 6-12 months |
Primary outcome
Movement
Time frame: Immediately following skin incision
The study is completed after assessment of patient movement with skin incision
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Baijal, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
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.