Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Undergoing Endoscopic Adenoidectomy in General Anesthesia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04466579|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea Postoperative Vomiting Emergence Delirium||Other: BIS monitor Other: Standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study subjects will be randomized into two study arms.|
|Masking:||None (Open Label)|
|Masking Description:||No masking is being used in this study.|
|Official Title:||Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Undergoing Endoscopic Adenoidectomy in General Anesthesia|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: BIS monitoring
Study subjects randomized in this study arm will have the depth of anesthesia controlled with the BIS monitor.
Other: BIS monitor
BIS monitor is used to control and monitor the depth of general anesthesia.
Active Comparator: Standard care
Study subjects randomized in this study arm will receive standard anesthesiology care according to the usual procedures used at the study centre.
Other: Standard care
Standard anesthesiology care according to the protocol of the study
- Incidence of PONV [ Time Frame: During the hospitalisation of the patient, i.e. up to 5 days ]The incidence of PONV will be observed and recorded using the Baxter Reetching Faces (BARF) scale and recording the number of PONV episodes.
- Incidence of ED [ Time Frame: During the hospitalisation of the patient, i.e. up to 5 days ]The incidence of ED will be observed and recorded using the PAED score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466579
|Contact: Petr Vávra, Ass.Prof.,MD,PhD||0042059737 ext email@example.com|
|Contact: Jiří Hynčica||0042059737 ext firstname.lastname@example.org|
|University Hospital Ostrava|
|Ostrava, Moravian-Silesian Region, Czechia, 70852|
|Contact: Petr Vávra, Ass.Prof.,MD,PhD 0042059737 ext 2544 email@example.com|
|Contact: Jiří Hynčica 0042059737 ext 2587 firstname.lastname@example.org|
|Principal Investigator: Michal Frelich, MD,PhD|
|Sub-Investigator: Jan Divák, MD,PhD|
|Sub-Investigator: Vojtěch Vodička, MD,PhD|
|Sub-Investigator: Filip Burša, MD,PhD|
|Sub-Investigator: Martin Formánek, MD,PhD|
|Principal Investigator:||Michal Frelich, MD,PhD||University Hospital Ostrava|