Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane

Conditions

• Pediatric Anesthesia

Eligibility Criteria

Sex

ALL

Age

1 Month - 36 Months

Healthy Volunteers

Accepted

Interventions

• Dexmedetomidine — DRUG
  Dexmedetomidine 9 arms

Study Details

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.

Key Dates

Start date

Feb 18, 2018

Status verified

Sep 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

Movement [ Time Frame: Immediately following skin incision ]

Central Contacts

• Margaret Owens-Stuberfield
  832-824-5800
  [email protected]

Locations (1)

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