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Effect of BIS-Guided Anesthesia on Postoperative Nausea and Vomiting in Pediatric Patients

NCT ID: NCT07189845

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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PONV BIS

Keywords

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ponv bıs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Parallel Assignment

Study Groups

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BIS GROUP

BIS monitoring will be visible, and anesthesia depth will be adjusted according to BIS values (40-60).

Group Type ACTIVE_COMPARATOR

BIS GROUP

Intervention Type DIAGNOSTIC_TEST

In the BIS group, monitoring will be visible and anesthesia depth will be maintained within a BIS value range of 40-60.

CONTROL GROUP

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

Group Type ACTIVE_COMPARATOR

CONTROL GROUP

Intervention Type DIAGNOSTIC_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.

Interventions

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BIS GROUP

In the BIS group, monitoring will be visible and anesthesia depth will be maintained within a BIS value range of 40-60.

Intervention Type DIAGNOSTIC_TEST

CONTROL GROUP

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children aged 3-8 years
* ASA physical status class I-II
* Scheduled for elective adenoidectomy
* Written informed consent obtained from parents

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Engin Çetin

OTHER_GOV

Sponsor Role lead

Responsible Party

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Engin Çetin

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Engin Çetin

Role: CONTACT

Phone: 532 120 60 04

Email: [email protected]

Facility Contacts

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MEHMET YILMAZ, Assoc. Prof.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 38982400 (View on PubMed)

Other Identifiers

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KSH-ANREA-EC-04

Identifier Type: -

Identifier Source: org_study_id