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

NCT ID: NCT07245654

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-10
• Study Completion Date: 2026-12-31

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.

Detailed Description

After approval by the Ethics Committee of the Brno University Hospital and registration at clinicaltrials.gov, the study will include patients meeting inclusive criteria. Pediatric patients aged 1 year to 19 years who undergo elective surgery under general anesthesia will be included in the study if the expected duration of the operation is more than 30 minutes.

Due to the observational nature of the study (no intervention, the monitoring used is a standard recommended part of anesthesia care), informed consent will not be required. Before induction of anesthesia, the electrodes of the CONOX device will be applied to the patient's forehead according to the manufacturer's recommendations and monitoring of the depth of anesthesia and analgesia will be initiated. Induction of anesthesia will be carried out according to the indications of the anesthesiologist (intravenously or by inhalation). During airway management, the depth of anesthesia and the level of analgesia and the patient's clinical response will be monitored. At the same time, the opioid analgesic used, the method of airway management and the occurrence of a burst suppression ratio will be monitored. Postoperatively, the occurrence of postoperative delirium in the recovery room will be monitored.

Conditions

Anaesthesia; Anesthesia Depth Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

prof. MUDr. Petr Štourač, Ph.D., LL.M, MBA, FESAIC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Štourač, prof.MD.Ph.D

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno

Locations

University Hospital Brno

Brno, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Tereza Bonischova, MD

Role: CONTACT

musilovate@gmail.com

00420724253223

Hana Harazim, MD, PhD

Role: CONTACT

harazim.hana@fnbrno.cz

00420777146704

Other Identifiers

KDAR 2025 ANIGAPP

Identifier Type: -

Identifier Source: org_study_id