Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children

Not Applicable

Completed

• Conditions: Children
• Interventions: Drug: dexmedetomidine

• Registration Number: NCT02261675
• Lead Sponsor: Cai Li

Brief Summary

The study was designed to define the interaction of intravenous infusion of dexmedetomidine, an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum alveolar concentration which can block adrenergic and cardiovascular responses to incision(MACbar) of sevoflurane as the measure of anesthetic potency.

Detailed Description

The investigators observed the effects of different doses of dexmedetomidine on the minimum alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in 50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric patients.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Status Verified: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-07
• Last Update Submitted: 2014-10-07
• Study First Posted: 2014-10-10
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• aged 2 to 6 yr
• American Society of anesthesiologists I or II
• scheduled to have general anesthesia and to have skin incisions on the abdomen

Exclusion Criteria

• anemia or abnormal preoperative electrolyte concentrations
• a history of cardiovascular or central nervous system diseases
• a history of pulmonary disease
• known hepatic or renal disease
• a body weight exceeding 50% of the upper limit of ideal body weight for height
• taking drugs with cardiovascular or central nervous system effects
• use of any experimental drug within the past 30 days
• allergy to any drug that may be administered during the study
• exposure to general anesthesia within the previous 7 days
• second- or third-degree atrioventricular block
• taking drugs preoperatively that would interfere with MAC determination(e.g.,opioids or sedatives)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D1 group	dexmedetomidine	children undergoing selective lower abdominal surgery received a bolus dose of 0.5 µg/kg dexmedetomidine followed by a continuous infusion of 0.5 µg/kg /h before induction
D2 group	dexmedetomidine	children undergoing selective lower abdominal surgery received a bolus dose of 1.0µg/kg dexmedetomidine followed by a continuous infusion of 1.0 µg/kg /h before induction

Primary Outcome Measures

Name	Time	Method
the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)	at once before incision and 5 min period after incision	A predetermined steady-state end-tidal sevoflurane concentration(4%) was maintained for at least 15 min before skin incision.we observed the change in Mean Blood Pressure or Heart rate to determined the next end-tidal sevoflurane concentration.Followed the modified Dixon up and down method to obtain MACBAR of every child.The MACBAR of sevoflurane and its 95% confidence interval were calculated by Sum Average method.