Monitoring the Depth of Anesthesia and Nociception During the Induction of General Anesthesia in Pediatric Patients

NCT07245654 | Recruiting

• 1 other identifier: KDAR 2025 ANIGAPP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative assessment of adequate depth of anesthesia and analgesia is currently a recommended part of routine anesthesia practice for all surgical procedures. In most cases, it is performed by monitoring and evaluating physiological parameters, which is insufficient, especially for the depth of anesthesia. The depth of anesthesia, when measured with the Conox device, is indicated by the qCON index, the recommended value for anesthesia management is between 40-60. Shallow (above 60) anesthesia may be associated with an increased incidence of perioperative wakefulness episodes, and deeper (below 40) anesthesia may lead to a more frequent occurrence of adverse effects of anesthesia, including emergent delirium in the postoperative period. In addition to assessing the depth of anesthesia, the Conox device also allows for instrumental assessment of analgesia. Inadequate analgesia increases postoperative discomfort and may contribute to an increased incidence of complications in anesthesia and during the postoperative period. Instrumental monitoring of the depth of anesthesia and analgesia increases the safety of anesthesia care. During perioperative care, periods with significant painful stimulation include not only the surgical procedure itself but also airway management during induction of general anesthesia, especially intubation. The hypothesis is - due to the significant painful stimulation during airway management during induction of anesthesia, adequate depth of anesthesia and analgesia may be insufficient and is associated with the patient's clinical response, which may be associated with the occurrence of postoperative delirium.

Conditions

Anaesthesia; Anesthesia Depth Monitoring

Keywords

depth of anesthesia; pediatric; nociception; awareness; depth of analgesia; airway management

Outcome Measures

Primary Outcomes (1)

• Depth of anesthesia

  Assessment of the depth of anesthesia, level of analgesia during airway management during induction of anesthesia, clinical response of the patient.

  Perioperative/Periprocedural

Secondary Outcomes (1)

• contributing factors

  Perioperative/Periprocedural

Eligibility Criteria

• Age: 1 Year - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

\- Pediatric patients (age 1-19 years) indicated for surgery under general anesthesia with airway management (laryngeal mask, orotracheal intubation, nasotracheal intubation) with expected duration of surgery more than 30 minutes

You may qualify if:

• Pediatric patients (age 1-19 years) indicated for surgery under general anesthesia with airway management (laryngeal mask, orotracheal intubation, nasotracheal intubation)
• CONOX monitoring available

You may not qualify if:

• Age out of range
• Use of ketamine during anesthesia care (premedication, analgesic, anesthetic)
• Expected duration of surgery less than 30 minutes
• CONOX monitoring unavailable

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

RECRUITING

Study Officials

• Petr Štourač, prof.MD.Ph.D

  University Hospital Brno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tereza Bonischova, MD

CONTACT

00420724253223; musilovate@gmail.com

Hana Harazim, MD, PhD

CONTACT

00420777146704; harazim.hana@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. MUDr. Petr Štourač, Ph.D., LL.M, MBA, FESAIC

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)