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

NCT07189845 | Completed

• 1 other identifier: KSH-ANREA-EC-04
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PONV; BIS

Keywords

ponv; bıs

Outcome Measures

Primary Outcomes (1)

• 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 1. Mild nausea 2. Severe nausea or a single vomiting episode 3. Severe nausea with multiple vomiting episodes or intractable PONV

  T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation

Secondary Outcomes (2)

• Emergence Time

  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

  0-24 hours postoperatively

Study Arms (2)

BIS GROUP

ACTIVE COMPARATOR

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

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

Diagnostic Test: CONTROL GROUP

Interventions

BIS GROUP DIAGNOSTIC_TEST

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

BIS GROUP

CONTROL GROUP 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.

CONTROL GROUP

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Engin Çetin: lead

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38982400 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Parallel Assignment
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 24, 2025
• Study Start: September 24, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)