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| Name | Class |
|---|---|
| Municipal Hospital Ostrava | OTHER |
| Havířov Hospital | UNKNOWN |
| Frýdek-Místek Hospital | UNKNOWN |
| Tomas Bata Hospital, Czech Republic |
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This study will investigate the impact of combining dexamethasone and bispectral index (BIS) monitoring on the incidence of postoperative nausea and vomiting, emergence delirium and recovery trajectories in children undergoing ear-nose-throat (ENT) surgery.
Immediately after securing the airway, an electrode will be attached and BIS monitoring will begin. This will be used to control the depth of general anaesthesia throughout the entire surgical procedure, with the aim of achieving BIS values of 40-60.
Intervention group: Following the administration of dexamethasone at the same dos-age as in the control group, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60.
Control group: Once access to the vascular system has been secured, dexamethasone will be administered intravenously at a dose of 0.15 mg/kg body weight, up to a maxi-mum of 5 mg. A non-functional electrode for bispectral index (BIS) monitoring will then be attached to the patient's forehead. The depth of anaesthesia will be controlled based on the minimum alveolar concentration (target MAC: 1-1.1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group - BIS monitoring | Experimental | Following the administration of dexamethasone, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60. |
|
| Control group - sham BIS monitoring | Experimental | A non-functional electrode for bispectral index (BIS) monitoring will then be attached to the patient's forehead. The depth of anaesthesia will be controlled based on the minimum alveolar concentration (target MAC: 1-1.1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS monitoring | Procedure | BIS monitoring will be used to guide the depth of anaesthesia in this intervention group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of BIS monitoring on the incidence of postoperative nausea and vomiting | Effect of BIS monitoring on the incidence of postoperative nausea and vomiting within 24 hours after surgery under general anaesthesia. Vomiting is defined as the expulsion of gastric contents through the oral cavity. Nausea is defined for the purposes of this study using the Baxter Animated Retching Face (BARF) score of 4 or more. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of BIS monitoring on the incidence of emergent delirium | Effect of BIS monitoring on the incidence of emergent delirium (Paediatric Anaesthesia Emergence Delirium (PAED) above 10 and Watcha scale above 3) in the PACU. | 1 hour from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | +42059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Michal Frelich, MD, Ph.D. | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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| OTHER |
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| Sham BIS monitoring | Procedure | Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration. |
|
| Frýdek-Místek Hospital | Frýdek-Místek | 738 01 | Czechia |
|
| Havířov Hospital | Havířov | 736 01 | Czechia |
|
| Municipal Hospital Ostrava | Ostrava | 728 80 | Czechia |
|
| Tomáš Baťa Hospital, Zlín | Zlín | 762 75 | Czechia |
|
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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