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Trial registered on ANZCTR


Registration number
ACTRN12613000679785
Ethics application status
Approved
Date submitted
17/06/2013
Date registered
20/06/2013
Date last updated
17/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Intranasal Dexmedetomidine Premedication on the Minimum Alveolar Concentration of Sevoflurane for tracheal intubation in children
Scientific title
The Effect of Intranasal Dexmedetomidine Premedication on the Minimum Alveolar Concentration of Sevoflurane for tracheal intubation in children
Secondary ID [1] 282685 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inhalation induction of anesthesia and tracheal intubation in children 289396 0
Condition category
Condition code
Anaesthesiology 289721 289721 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GroupD1 received 1mcg/Kg intranasal dexmedetomidine premedication 60 min before general anaesthesia; GroupD2 received 2mcg/Kg intranasal dexmedetomidine premedication 60 min before general anaesthesia.Before tracheal intubation was attempted, the end-tidal concentration of sevoflurane was kept constant at the predetermined value at least 15 min, Once the response to tracheal intubation was recorded, further administration of anesthetic and analgesic agents was at the attending anesthesiologist’s discretion.
Intervention code [1] 287345 0
Treatment: Drugs
Comparator / control treatment
Group S received intranasal saline premedication 60 min before general anaesthesia
Control group
Placebo

Outcomes
Primary outcome [1] 289813 0
the minimum alveolar concentration of sevoflurane for tracheal intubation (MACTI); Patient’s responses to tracheal intubation were classified as ‘no movement’ or ‘movement’. ‘No movement’ was defined as the absence of purposeful movement of the extremities, movement of the vocal cords preventing intubation, and coughing or bucking during or immediately after intubation. The values of MACTI were obtained by calculating the midpoint concentration of all independent response cross-overs in which a positive response was followed by a negative response.
Timepoint [1] 289813 0
At the time of tracheal intubation
Secondary outcome [1] 303291 0
included induction quality
Timepoint [1] 303291 0
Induction quality was briefly evaluated according to a four-point scale during the inhalation induction with sevoflurane
Secondary outcome [2] 303292 0
Incidence of adverse events(e.g.hypotention,bradycardia);

Clinically significant hypotention or bradycardia, defined as > 30% decrease in mean arterial pressure or heart rate compared with baseline.
Timepoint [2] 303292 0
During the study period

Eligibility
Key inclusion criteria
American Society of Anesthesiologists physical status I-II children scheduled to undergo general anesthesia for elective minor surgery
Minimum age
3 Years
Maximum age
7 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with airway malformation, clinical evidence of a difficult airway, any sign of upper respiratory infection, or asthma were excluded. Patients taking medication known to affect anesthetic requirements were also excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis
The sample size was calculated based on the assumed standard deviation of the sevoflurane dose from a previous study.Twenty-eight patients were required in each group to detect a mean difference of sevoflurane 0.32% (2SD) between the groups at a power of 0.8 and a P-value of 0.05. The sample size was increased to 90 patients to allow for dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5146 0
China
State/province [1] 5146 0
Fujian Province

Funding & Sponsors
Funding source category [1] 287457 0
Self funded/Unfunded
Name [1] 287457 0
Yusheng Yao
Address [1] 287457 0
No.134 Dongjie Street, Fujian Provincial Hospital, Fuzhou, Fujian, China, 350001
Country [1] 287457 0
China
Primary sponsor type
Individual
Name
Yusheng Yao
Address
No.134 Dongjie Street, Fujian Provincial Hospital, Fuzhou, Fujian, China, 350001
Country
China
Secondary sponsor category [1] 286201 0
Individual
Name [1] 286201 0
Yanqing Chen
Address [1] 286201 0
No.134 Dongjie Street,Fujian Provincial Hospital, Fuzhou, Fujian, China, 350001
Country [1] 286201 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289432 0
The Ethics and Committee of Fujian Provincial Hospital
Ethics committee address [1] 289432 0
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Ethics committee country [1] 289432 0
China
Date submitted for ethics approval [1] 289432 0
26/04/2013
Approval date [1] 289432 0
01/06/2013
Ethics approval number [1] 289432 0
FJSL-2013-06-01

Summary
Brief summary
Sevoflurane is generally employed for inhalation induction of anesthesia and tracheal intubation in children without muscle relaxant.Clinical trials have demonstrated that intranasal dexmedetomidine is an effective sedative for premedication in children.The ability of dexmedetomidine to reduce both the inhalation anesthetic and opioid analgesic requirements has been confirmed previously. However, to date, the effects of dexmedetomidine premedication on the minimum alveolar concentration of sevoflurane for tracheal intubation (MACTI) in pediatric patients is still undetermined.
Trial website
Trial related presentations / publications
Intranasal dexmedetomidine premedication reduces the minimum alveolar concentration of sevoflurane for tracheal intubation in children: a randomized trial.
Yao Y, Qian B, Chen Y, Zhou L, Liu J.
J Clin Anesth. 2014 Jun;26(4):309-14. doi: 10.1016/j.jclinane.2013.12.012. Epub 2014 May 26.
PMID: 24875890
Public notes

Contacts
Principal investigator
Name 40626 0
Dr Yusheng Yao
Address 40626 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 40626 0
China
Phone 40626 0
+86 13559939629
Fax 40626 0
Email 40626 0
fjslyys@gmail.com
Contact person for public queries
Name 40627 0
Dr Yusheng Yao
Address 40627 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 40627 0
China
Phone 40627 0
+86 13559939629
Fax 40627 0
Email 40627 0
fjslyys@gmail.com
Contact person for scientific queries
Name 40628 0
Dr Yusheng Yao
Address 40628 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 40628 0
China
Phone 40628 0
+86 13559939629
Fax 40628 0
Email 40628 0
fjslyys@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary