Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane

NCT03384563 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: H-37186
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

pediatric; anesthesia; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Movement

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

  Immediately following skin incision

Study Arms (9)

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.

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.

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.

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.

Drug: Dexmedetomidine

Placebo 6-12 months

PLACEBO COMPARATOR

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

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.

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.

Drug: Dexmedetomidine

Placebo 1-3 years

PLACEBO COMPARATOR

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

Drug: Dexmedetomidine

Placebo 1-6 months

PLACEBO COMPARATOR

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

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 9 arms

Also known as: Precedex

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

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rahul Baijal, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Owens-Stuberfield

CONTACT

832-824-5800; owensstu@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 27, 2017
• Study Start: February 18, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)