NCT01065701

Brief Summary

Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

February 7, 2010

Last Update Submit

October 24, 2017

Conditions

Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital

Outcome Measures

Primary Outcomes (1)

  • proportion of children attained satisfactory sedation

    one hour

Secondary Outcomes (1)

  • time to onset of sedation

    one hour

Study Arms (2)

1mcg/kg

ACTIVE COMPARATOR

1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction

Drug: Dexmedetomidine

2mcg/kg

ACTIVE COMPARATOR

2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia

1mcg/kg2mcg/kg

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1-12 years old
  • American Society of Anesthesiologists (ASA) 1-2
  • Elective surgery
  • Children with autism or pervasive personality disorder

You may not qualify if:

  • American Society of Anaesthesiologists (ASA) 3-5
  • Allergy or hypersensitive reaction to dexmedetomidine
  • Known cardiac arrhythmia or congenital heart disease
  • Mentally disabled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QUeen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Vivian M Yuen, MBBS

    Associate Consultant, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 7, 2010

First Posted

February 9, 2010

Study Start

July 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

HK(1)