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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01993992
Other study ID # 201310021RIND
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 3, 2013
Last updated July 7, 2015
Start date December 2013
Est. completion date December 2016

Study information

Verified date July 2015
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.


Description:

Outcome measures

1. Post-operative emergence delirium, observed with an average duration up to 24 hours

2. Sedatives used in recovery unit


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 16 Years
Eligibility Inclusion criteria:

- American Society Anesthesia (ASA) risks classification I or II

Exclusion criteria:

- Parents who have cognitive problems

- Parents who have difficulty finishing questionnaire

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary degree of emergence delirium after operation, with an average duration up to 24 hours No
Secondary recovery room stay time after operation, with an average duration up to 24 hours No
Secondary Sedatives used in recovery room after operation, with an average duration up to 24 hours No
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