The effect of special brainwaves may reduce sedation level in children

The effect of audio-visual brainwave entrainment on sedation level in children - audio-visual attraction and sedation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005303-40-AT

Enrollment

Unknown

Registered

2012-11-26

Start date

2013-01-02

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children (> 1a) who are undergoing lower body surgery in caudal anesthesia require additional sedation to maintain an adequate intraoperative sedation level. Audio-visual entrainment does have a positive influence on functions of the brain and can be used to produce sedation. We would like to prove that with the help of this audio-visual entrainment the amount of sedation medication can be reduced.

Interventions

Trade Name: Propofol Product Name: Propofol Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: Propofol CAS Number: 2078-54-8 Concentration unit: mg/ml milligram(s)/millilitre C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Planned lower body surgery will be done with caudal anesthesia and propofol sedation •Age between 1 and 6 years (with a maximum weight of 25kg) Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Children’s / parent's refusal •Children suffering from neurological diseases e.g. epilepsy who get administered neurological, hypnotic medication regularly •Contraindications for a propofol sedation regime •Children suffering from related harm or deafness •Brain injuries in patient´s medical history

Design outcomes

Primary

Measure	Time frame
Main Objective: Additionally added audio-visual brainwave entrainment on children who are undergoing surgery with caudal anesthesia may reduce the demand of sedation drugs to maintain the same level of sedation;Secondary Objective: not applicable;Primary end point(s): Intraoperative depth of sedation are measured. Sedation drugs are reduced until achievement a BIS - Index between 60 and 70. ;Timepoint(s) of evaluation of this end point: Every five minutes until a BIS of 60 to 70 is achived	—

Measure

Time frame

Main Objective: Additionally added audio-visual brainwave entrainment on children who are undergoing surgery with caudal anesthesia may reduce the demand of sedation drugs to maintain the same level of sedation;Secondary Objective: not applicable;Primary end point(s): Intraoperative depth of sedation are measured. Sedation drugs are reduced until achievement a BIS - Index between 60 and 70. ;Timepoint(s) of evaluation of this end point: Every five minutes until a BIS of 60 to 70 is achived

—

Secondary

Measure	Time frame
Secondary end point(s): not appicable;Timepoint(s) of evaluation of this end point: not appicable	—

Countries

Austria

Contacts

Public ContactDaniela Marhofer

Medizinsche Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

daniela.marhofer@meduniwien.ac.at+431404004102

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026