Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children

October 7, 2014 updated by: Cai Li

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
children undergoing selective lower abdominal surgery received saline before induction
Experimental: 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
Drug: 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.
Other Names:
  • precedex
Experimental: 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
Drug: 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.
Other Names:
  • precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at once before incision and 5 min period after incision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cai Li

Investigators

  • Principal Investigator: Xuan Ke Liu, Ph.d, Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 10, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Macbar DEX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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