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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00005064
Date of registration:	03/11/2014
Prospective Registration:	No
Primary sponsor:	Medizinische Universität Wien
Public title:	The effect of audio-visual brainwave entrainment on sedation level in children
Scientific title:	The effect of audio-visual brainwave entrainment on sedation level in children
Date of first enrolment:	27/11/2013
Target sample size:	60
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00005064
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: prevention
Phase:	N/A

Countries of recruitment
Austria

Contacts

Name:	Wolfgang Klug
Address:	Spitalgasse 23 1090 Wien Austria
Telephone:	0043 1 40400 4100
Email:	wolfgang.klug@meduniwien.ac.at
Affiliation:	Medizinische Universität Wien

Name:	Wolfgang Klug
Address:	Spitalgasse 23 1090 Wien Austria
Telephone:	0043 1 40400 4100
Email:	wolfgang.klug@meduniwien.ac.at
Affiliation:	Medizinische Universität Wien

Key inclusion & exclusion criteria

Inclusion criteria: operations under the level of the umbilicus in caudal anaesthesia
Exclusion criteria: parents refusal, contraindication for caudal anaesthesia and sedation

Age minimum: 0 Years
Age maximum: 6 Years
Gender: All

Health Condition(s) or Problem(s) studied

K40.0
N47

Bilateral inguinal hernia, with obstruction, without gangrene

Redundant prepuce, phimosis and paraphimosis

K40.0

Intervention(s)

Group 1: group1: propofol sedation 5mg/kg/h

Group 2: group2:This group will be startet with Propofol 5mg/kg/h continuously equal to the group 1. However, this group will get an audio visual stimulation additionally (administered by earphones and light shimmering glasses). Every 5 minutes the dosage of propofol will be reduced in 1mg/kg steps, while the level of sedation will be maintained by the audiovisual stimulation alone. The target BIS is between 60-70.

Primary Outcome(s)

Primary: Depth of sedation evaluatet and meassured bei BIS (Bispectral Index)

Secondary Outcome(s)

Reduction of painmedication in the recovery room

Secondary ID(s)

Source(s) of Monetary Support

Medizinische Universität Wien

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 04/10/2012
Contact:

Ethikkommission Med.Universität Wien [Ethikkommission der MUW Borschkegasse 6b 1090 Wien]

Results

Results available:
Date Posted:
Date Completed:	31/05/2016
URL:	http://drks.de/search/en/trial/DRKS00005064#studyResults

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