Anaesthesia Clinical Trial
Official title:
Monitoring the Depth of Anaesthesia in Children in the Course of a Surgical Procedure Using the BIS Monitor - Prospective Randomized Study
Verified date | March 2018 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | November 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 15 Years |
Eligibility |
Inclusion Criteria: - appropriate age - informed consent form signed by both parents (according to national legislation) - need to undergo a procedure in general anaesthesia - ASA I classification Exclusion Criteria: - non-signing of the informed consent form by both parents - ASA classification higher than I |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Decrease of complications at recovery room | The decrease in complications at recovery room will be measured and compared in both groups. | 24 months | |
Primary | Occurrence of perioperative complications | The occurrence of perioperative complications due to inappropriate depth of general anaesthesia will be observed. | 24 months | |
Secondary | Shortening of the emergence from general anaesthesia | The time of emergence from general anaesthesia will be measured and compared in both groups. | 24 months | |
Secondary | Decrease in the amount of inhalation anaesthetic used | The decrease in the amount of inhalation anaesthetic used will be measured and compared in both groups. | 24 months | |
Secondary | Decrease in the amount of analgesics used | The decrease in the amount of analgesics used will be measured and compared in both groups. | 24 months |
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