PONVNCT07189845
Effect of BIS-Guided Anesthesia on Postoperative Nausea and Vomiting in Pediatric Patients
A study testing BIS GROUP in people with PONV and BIS, run by Engin Çetin at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial will evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3-8 years undergoing elective adenoidectomy. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- What is being tested?
- BIS GROUP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-8 years
- ASA physical status class I-II
- Scheduled for elective adenoidectomy
- Written informed consent obtained from parents
Who cannot join
- Children with a previous history of PONV
- Patients receiving antiemetic, steroid, or sedative medication
- Acute upper respiratory tract infection
- History of neurological or psychiatric disorders
- Body mass index (BMI) below the 5th percentile or above the 95th percentile
- Anatomical airway abnormalities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kocaeli City Hospital
Kocaeli, Izmit, 41100
About this study
Official title: Effect of Bispectral Index (BIS)-Guided Anesthesia on Postoperative Nausea and Vomiting in Children Aged 3 to 8 Years: A Prospective Randomized Controlled Trial
This randomized controlled trial will evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3-8 years undergoing elective adenoidectomy. Fifty-eight patients will be randomized to BIS-guided anesthesia (target 40-60) or standard clinical management. The primary outcome is PONV incidence within 24 hours. Secondary outcomes include antiemetic use, emergence time, hospital stay, and parental satisfaction.
Read the detailed description
This prospective, randomized, double-blind controlled trial aims to evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3 to 8 years undergoing elective adenoidectomy. PONV is a common postoperative complication in pediatric surgery, with reported incidences of 30-70%, leading to delayed oral intake, prolonged hospital stay, and reduced parental satisfaction. BIS monitoring provides an objective EEG-based measure of anesthesia depth, allowing precise titration of anesthetic agents and potentially reducing postoperative complications. While adult studies and meta-analyses have shown that BIS guidance decreases the incidence of PONV, evidence in pediatric populations remains limited. A total of 58 ASA I-II patients will be randomized into two groups: BIS-guided anesthesia (target 40-60) and standard clinical parameter-guided anesthesia with the BIS screen hidden. The primary outcome is the incidence of PONV within 24 hours postoperatively. Secondary outcomes include antiemetic use, severity of PONV, time to emergence, length of hospital stay, and parental satisfaction assessed with a Likert scale. The findings of this trial are expected to clarify the role of BIS monitoring in improving postoperative outcomes in pediatric anesthesia.
- Being tested
- BIS GROUP, CONTROL GROUP
- Keywords
- ponv, bıs
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS GROUPDiagnostic test
In the BIS group, monitoring will be visible and anesthesia depth will be maintained within a BIS value range of 40-60.
CONTROL GROUPDiagnostic test
In the control group, the BIS monitor will be applied with the screen concealed from the investigator, and anesthesia depth will be guided solely by clinical parameters.
| Study group | Role | What they receive |
|---|---|---|
| BIS GROUP | Active comparator | BIS monitoring will be visible, and anesthesia depth will be adjusted according to BIS values (40-60). Receives: Diagnostic Test: BIS GROUP |
| CONTROL GROUP | Active comparator | In the control group, the BIS monitor will be applied with the screen concealed from the investigator, and anesthesia depth will be guided solely by clinical parameters Receives: Diagnostic Test: CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively.
PONV will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. The Postoperative nausea and vomiting (PONV) will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. PONV severity will be evaluated using a predefined four-point ordinal scale based on the presence and frequency of nausea and vomiting, as follows:
0: No nausea or vomiting
- Mild nausea
- Severe nausea or a single vomiting episode
- Severe nausea with multiple vomiting episodes or intractable PONV
Measured: T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation
Secondary outcomes (2)
Emergence Time
Emergence time (defined as the time from discontinuation of sevoflurane until the patient opens their eyes in response to verbal command)
Measured: From discontinuation of sevoflurane at the end of surgery until eye opening in response to verbal command, assessed up to 30 minutes
Antiemetic use and timing
The administration of rescue antiemetic drugs will be recorded for each patient within the first 24 hours after surgery. The specific agent used (e.g., ondansetron, dexamethasone), the time of administration, and the number of doses will be documented from anesthesia and nursing records. The outcome will be expressed as the proportion of patients requiring antiemetic medication and the mean time to first administration
Measured: 0-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start24 Sep 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PONVStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engin Çetin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Engin Çetin, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189845
- Sponsor's protocol ID
- KSH-ANREA-EC-04
- Status last verified
- Feb 2026
- First submitted
- 2 Sep 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frelich M, Sklienka P, Romanova T, Nemcova S, Bilena M, Strakova H, Lecbychova K, Jor O, Formanek M, Bursa F. The effect of BIS-guided anaesthesia on the incidence of postoperative nausea and vomiting in children: a prospective randomized double-blind study. BMC Anesthesiol. 2024 Jul 9;24(1):228. doi: 10.1186/s12871-024-02610-w.
PubMed 38982400Cetin E, Sencan A, Yuksek A, Gunel B, Zeytun F, Yilmaz M. The effect of BIS-guided sevoflurane anesthesia on postoperative nausea and vomiting in pediatric adenoidectomy: a prospective randomized controlled trial. Sao Paulo Med J. 2026 Aug 31;144(3):e20263631. doi: 10.1590/1516-3180.2026.3631.13052026. eCollection 2026.
PubMed 42690324
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bispectral Index (BIS)-Guided Anesthesia on Postoperative Nausea and Vomiting in Children Aged 3 to 8 Years: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07189845
- Acronym / sponsor ID
- KSH-ANREA-EC-04
- Keywords
- ponv, bıs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Engin ÇetinOther government
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 24 Sep 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 randomized controlled trial will evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3-8 years undergoing elective adenoidectomy. Fifty-eight patients will be randomized to BIS-guided anesthesia (target 40-60) or standard clinical management. The primary outcome is PONV incidence within 24 hours. Secondary outcomes include antiemetic use, emergence time, hospital stay, and parental satisfaction.
Detailed description
This prospective, randomized, double-blind controlled trial aims to evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3 to 8 years undergoing elective adenoidectomy. PONV is a common postoperative complication in pediatric surgery, with reported incidences of 30-70%, leading to delayed oral intake, prolonged hospital stay, and reduced parental satisfaction. BIS monitoring provides an objective EEG-based measure of anesthesia depth, allowing precise titration of anesthetic agents and potentially reducing postoperative complications. While adult studies and meta-analyses have shown that BIS guidance decreases the incidence of PONV, evidence in pediatric populations remains limited. A total of 58 ASA I-II patients will be randomized into two groups: BIS-guided anesthesia (target 40-60) and standard clinical parameter-guided anesthesia with the BIS screen hidden. The primary outcome is the incidence of PONV within 24 hours postoperatively. Secondary outcomes include antiemetic use, severity of PONV, time to emergence, length of hospital stay, and parental satisfaction assessed with a Likert scale. The findings of this trial are expected to clarify the role of BIS monitoring in improving postoperative outcomes in pediatric anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| BIS GROUP | Active comparator | Diagnostic Test: BIS GROUPBIS monitoring will be visible, and anesthesia depth will be adjusted according to BIS values (40-60). |
| CONTROL GROUP | Active comparator | Diagnostic Test: CONTROL GROUPIn the control group, the BIS monitor will be applied with the screen concealed from the investigator, and anesthesia depth will be guided solely by clinical parameters |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3-8 years
- ASA physical status class I-II
- Scheduled for elective adenoidectomy
- Written informed consent obtained from parents
Key exclusion criteria (6 listed)
- Children with a previous history of PONV
- Patients receiving antiemetic, steroid, or sedative medication
- Acute upper respiratory tract infection
- History of neurological or psychiatric disorders
- Body mass index (BMI) below the 5th percentile or above the 95th percentile
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 GROUPIn the BIS group, monitoring will be visible and anesthesia depth will be maintained within a BIS value range of 40-60. | Diagnostic test | BIS GROUP |
| CONTROL GROUPIn the control group, the BIS monitor will be applied with the screen concealed from the investigator, and anesthesia depth will be guided solely by clinical parameters. | Diagnostic test | CONTROL GROUP |
Primary outcome
Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively.
Time frame: T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation
PONV will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. The Postoperative nausea and vomiting (PONV) will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. PONV severity will be evaluated using a predefined four-point ordinal scale based on the presence and frequency of nausea and vomiting, as follows: 0: No nausea or vomiting 1. Mild nausea 2. Severe nausea or a single vomiting episode 3. Severe nausea with multiple vomiting episodes or intractable PONV
2 secondary outcomes
Emergence Time
Time frame: From discontinuation of sevoflurane at the end of surgery until eye opening in response to verbal command, assessed up to 30 minutes
Antiemetic use and timing
Time frame: 0-24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 38982400Frelich M, Sklienka P, Romanova T, Nemcova S, Bilena M, Strakova H, Lecbychova K, Jor O, Formanek M, Bursa F. The effect of BIS-guided anaesthesia on the incidence of postoperative nausea and vomiting in children: a prospective randomized double-blind study. BMC Anesthesiol. 2024 Jul 9;24(1):228. doi: 10.1186/s12871-024-02610-w.
- Derived from this study: PubMed 42690324Cetin E, Sencan A, Yuksek A, Gunel B, Zeytun F, Yilmaz M. The effect of BIS-guided sevoflurane anesthesia on postoperative nausea and vomiting in pediatric adenoidectomy: a prospective randomized controlled trial. Sao Paulo Med J. 2026 Aug 31;144(3):e20263631. doi: 10.1590/1516-3180.2026.3631.13052026. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS GROUP in people with PONV and BIS, run by Engin Çetin at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively. (time frame: T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07189845, which also lists 2 linked publications.
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 12 Feb 2026.