Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane

September 17, 2025 updated by: Rahul Baijal, Baylor College of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Margaret Owens-Stuberfield
  • Phone Number: 832-824-5800
  • Email: owensstu@bcm.edu

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

Exclusion Criteria:

  1. Interstitial lung disease, chest wall disease, or bronchospastic disease with no flare-ups in the past 2 weeks of presentation
  2. History of difficult intubation or ventilation
  3. Airway malformation
  4. Congenital heart disease
  5. Cardiac arrhythmias
  6. Central nervous system disease, including developmental delay, cerebral palsy, or seizure disorder
  7. History of or family history of malignant hyperthermia
  8. Electrolyte disorders
  9. Gastrointestinal disease
  10. Hepatic dysfunction
  11. Renal dysfunction
  12. Metabolic disease, such as diabetes
  13. Obesity, defined as a body mass index greater than the 95% percentile for age
  14. 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.

Inclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dexmedetomidine 0.5 mcg/kg 1-6 months
Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Active Comparator: Dexmedetomidine 1 mcg/kg 1-6 months
Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Active Comparator: Dexmedetomidine 0.5 mcg/kg 6-12 months
Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Active Comparator: Dexmedetomidine 1 mcg/kg 6-12 months
Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Placebo Comparator: Placebo 6-12 months
Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Active Comparator: Dexmedetomidine 0.5 mcg/kg 1-3 years
Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Active Comparator: Dexmedetomidine 1 mcg/kg 1-3 years
Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Placebo Comparator: Placebo 1-3 years
Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex
Placebo Comparator: Placebo 1-6 months
Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Drug: Dexmedetomidine
Dexmedetomidine 9 arms
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Movement
Time Frame: Immediately following skin incision
The study is completed after assessment of patient movement with skin incision
Immediately following skin incision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rahul Baijal, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-37186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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