Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children

NCT02261675 | Completed DMC

• 1 other identifier: Macbar DEX
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Children

Keywords

dexmedetomidine; sevoflurane; MAC bar; drug interaction; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

control group

NO INTERVENTION

children undergoing selective lower abdominal surgery received saline before induction

D1 group

EXPERIMENTAL

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

D2 group

EXPERIMENTAL

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

Interventions

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.

Also known as: precedex

D1 group; D2 group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cai Li: lead

Related 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. doi: 10.1097/00000542-200402000-00012.

  PMID: 14739797 RESULT

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xuan Ke Liu, Ph.d

  Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 10, 2014
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 10, 2014

Record last verified: 2014-10