Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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control group

children undergoing selective lower abdominal surgery received saline before induction

Group Type NO_INTERVENTION

No interventions assigned to this group

D1 group

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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.

D2 group

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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.

Interventions

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dexmedetomidine

children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.

Intervention Type DRUG

Other Intervention Names

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precedex

Eligibility Criteria

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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)

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No