Tonsil HypertrophyBISDEXNCT07299435
Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children
A study testing BIS monitoring in people with Tonsil Hypertrophy, run by University Hospital Ostrava at 5 sites in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Tonsil Hypertrophy
- What is being tested?
- BIS monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,508 participants
- Where
- 5 sitesCzechia
- Study dates
- 5 Jan 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 2 to 8 years undergoing endoscopic adenoidectomy
- parental/child consent
- ASA I-II (American Society of Anaesthesiologists Physical Status)
- no central nervous system (CNS) or gastrointestinal tract (GIT) disease
- no corticosteroid medication
Who cannot join
- Parent/child disapproval
- ASA III and above (American Society of Anaesthesiologists Physical Status)
- central nervous system (CNS) or gastrointestinal tract (GIT) disease
- chronic corticosteroid therapy
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Czechia5 sites
Frýdek-Místek Hospital
Frýdek-Místek, 738 01
Kateřina Kusznírová, MD, +42055841 ext. 5111, info@nemfm.cz
Kusznírová, MD
Havířov Hospital
Havířov, 736 01
Daniel Kmec, MD, +42059649 ext. 1111, sekretariat@nemhav.cz
Daniel Kmec, MD
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, +42059737 ext. 2587, jiri.hyncica@fno.cz
Michal Frelich, MD, Ph.D.
Municipal Hospital Ostrava
Ostrava, 728 80
Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA, +42059619 ext. 2555, martin.formanek@mnof.cz
Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA
Tomáš Baťa Hospital, Zlín
Zlín, 762 75
Klára Nekvindová, MD, +42057755 ext. 1111, podatelna@bnzlin.cz
Klára Nekvindová, MD
About this study
Official title: Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children: a Multicenter Prospective Double-blind Study (BISDEX TRIAL)
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.
Read the detailed description
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).
- Conditions
- Tonsil Hypertrophy
- Being tested
- BIS monitoring, Sham BIS monitoring
- Keywords
- postoperative nausea and vomiting, emergence delirium, children, ENT surgery
- Medical subject headings
- Postoperative Nausea and Vomiting, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS monitoringProcedure or surgery
BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.
Sham BIS monitoringProcedure or surgery
Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: BIS monitoring |
| 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). Receives: Procedure: Sham BIS monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 1 hour from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start5 Jan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsil HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- Municipal Hospital Ostrava, Havířov Hospital, Frýdek-Místek Hospital, Tomas Bata Hospital, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Michal Frelich, MD, Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299435
- Sponsor's protocol ID
- FNO-KARIM-BISDEX
- Acronym
- BISDEX
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children: a Multicenter Prospective Double-blind Study (BISDEX TRIAL)
- ClinicalTrials.gov ID
- NCT07299435
- Acronym / sponsor ID
- BISDEX / FNO-KARIM-BISDEX
- Conditions
- Tonsil Hypertrophy
- Keywords
- postoperative nausea and vomiting, emergence delirium, children, ENT surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,508 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- Municipal Hospital Ostrava, Havířov Hospital, Frýdek-Místek Hospital, Tomas Bata Hospital, Czech Republic
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - BIS monitoring | Experimental | Procedure: BIS monitoringFollowing 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 | Procedure: Sham BIS monitoringA 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). |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children aged 2 to 8 years undergoing endoscopic adenoidectomy
- parental/child consent
- ASA I-II (American Society of Anaesthesiologists Physical Status)
- no central nervous system (CNS) or gastrointestinal tract (GIT) disease
- no corticosteroid medication
Key exclusion criteria (4 listed)
- Parent/child disapproval
- ASA III and above (American Society of Anaesthesiologists Physical Status)
- central nervous system (CNS) or gastrointestinal tract (GIT) disease
- chronic corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS monitoringBIS monitoring will be used to guide the depth of anaesthesia in this intervention group. | Procedure or surgery | Intervention group - BIS monitoring |
| Sham BIS monitoringSham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration. | Procedure or surgery | Control group - sham BIS monitoring |
Primary outcome
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting
Time frame: 24 hours
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.
1 secondary outcome
Effect of BIS monitoring on the incidence of emergent delirium
Time frame: 1 hour from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Frelich, MD, Ph.D. principal investigator
University Hospital Ostrava
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS monitoring in people with Tonsil Hypertrophy, run by University Hospital Ostrava at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (+42059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.