Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261675
• Other study ID #: Macbar DEX
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: October 7, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Children

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cai Li

References & Publications (1)

Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)	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	Yes