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BIS Monitoring of the Depth of Anaesthesia in Children

NCT02664142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-03-23

No results posted yet for this study

Summary

General anaesthesia (GA) is, according to many definitions, the greatest gift presented to the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it is necessary to observe the clinical condition of the patient, and at the same time monitor the patient's overall condition. With the currently available options of GA management (e.g. use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in combination with various methods of topical anaesthesia) the importance of methods measuring the depth of GA increases. The depth of GA may be defined as a continuous progressive decreasing of the central nervous system, together with a decreased reactivity to stimuli. In the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening during a surgical procedure may result in significant psychological complications (e.g. post-traumatic stress disorder), and the patient may suffer from a serious long-time disorder.

Conditions

  • General Surgery
  • Anaesthesia

Interventions

PROCEDURE

BIS Group

BIS monitoring will be used in the BIS Group patients. The BIS value will be known to the anaesthetist, who will be able to act accordingly.

PROCEDURE

Non-BIS Group

BIS monitoring will be used in the Non-BIS Group patients. The BIS value will NOT be known to the anaesthetist and will be observed by a trained co-investigator, with subsequent evaluation.

DRUG

Anaesthetics

Anaesthetics will be administered in both experimental groups, in order to maintain the required general anaesthesia.

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Jan Divak, MD · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Days
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-09-30
Completion
2017-11-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02664142 on ClinicalTrials.gov