Recruiting

Dexmedetomidine

Sponsor:

Baylor College of Medicine

Code:

NCT03384563

Conditions

Pediatric Anesthesia

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

Interventions

Dexmedetomidine

Study Details

Brief 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.

Conditions

Pediatric Anesthesia

Study ID

NCT03384563

Start date

Feb 18, 2018

Status verified date

Sep, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

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 Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

placebo comparator: Placebo 6-12 months

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

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.

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.

placebo comparator: Placebo 1-3 years

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

placebo comparator: Placebo 1-6 months

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Interventions

Dexmedetomidine

Dexmedetomidine 9 arms

Primary outcome measure

  • Movement [ Time Frame: Immediately following skin incision ]

Central Contacts and Locations

Central contacts

Margaret Owens-Stuberfield

832-824-5800owensstu@bcm.edu

Locations

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Baylor College of Medicine

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • pediatric
  • anesthesia
  • dexmedetomidine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2025-09-22.