Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children

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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Key information

Conditions

Children

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine

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.

Other names: precedex

Primary outcomes

the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cai Li

Other

Registry information

Official study title

Dexmedetomidine Augments Block of Sympathetic Responses to Skin Incision During Sevoflurane Anesthesia in Children

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Oct 10, 2014
Registry last updated: Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed