Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Undergoing Endoscopic Adenoidectomy in General Anesthesia

NCT04466579 | Completed

• 1 other identifier: FNO-KARIM-14-PONV-ED
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study has been designed as a prospective randomized clinical trial. Due to the use of a bispectral (BIS) monitor in the interventional arm, the study will not be blinded for the anesthetist. The total planned number of study subjects is 100. Patients will be randomly randomized upon arrival to the operating theatre (using the envelope method) into the interventional arm (BIS monitoring of the depth of general anesthesia), and into the control group (standard management of general anesthesia to minimum alveolar concentration (MAC) 1,0). The target values of the depth of general anesthesia according to BIS are between 40 and 60.

Conditions

Postoperative Nausea; Postoperative Vomiting; Emergence Delirium

Keywords

postoperative nausea; postoperative vomiting; emergence delirium; bispectral monitor; pediatric anesthesia; adenoidectomy; general anesthesia

Outcome Measures

Primary Outcomes (2)

• Incidence of PONV

  The incidence of PONV will be observed and recorded using the Baxter Reetching Faces (BARF) scale and recording the number of PONV episodes.

  During the hospitalisation of the patient, i.e. up to 5 days

• Incidence of ED

  The incidence of ED will be observed and recorded using the PAED score.

  During the hospitalisation of the patient, i.e. up to 5 days

Study Arms (2)

BIS monitoring

EXPERIMENTAL

Study subjects randomized in this study arm will have the depth of anesthesia controlled with the BIS monitor.

Other: BIS monitor

Standard care

ACTIVE COMPARATOR

Study subjects randomized in this study arm will receive standard anesthesiology care according to the usual procedures used at the study centre.

Other: Standard care

Interventions

BIS monitor OTHER

BIS monitor is used to control and monitor the depth of general anesthesia.

BIS monitoring

Standard care OTHER

Standard anesthesiology care according to the protocol of the study

Standard care

Eligibility Criteria

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

You may qualify if:

• years of age
• Indication for the performance of endoscopic adenoidectomy in general anesthesia
• ASA I a II
• Consent of a parent/a guardian

You may not qualify if:

• ASA III and more
• Disapproval of a parent/a guardian
• Disapproval of the patient
• Allergies to medication used in the course of the study
• Contraindication of inhalation introduction to anesthesia and the way of securing breathing passageways in the study, according to the attending anesthetist

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (7)

• Kovac AL. Management of postoperative nausea and vomiting in children. Paediatr Drugs. 2007;9(1):47-69. doi: 10.2165/00148581-200709010-00005.

  PMID: 17291136 BACKGROUND

• Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

  PMID: 24356162 BACKGROUND

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

  PMID: 10485781 BACKGROUND

• Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. doi: 10.1097/ACO.0000000000000076.

  PMID: 24784918 BACKGROUND

• Locatelli BG, Ingelmo PM, Emre S, Meroni V, Minardi C, Frawley G, Benigni A, Di Marco S, Spotti A, Busi I, Sonzogni V. Emergence delirium in children: a comparison of sevoflurane and desflurane anesthesia using the Paediatric Anesthesia Emergence Delirium scale. Paediatr Anaesth. 2013 Apr;23(4):301-8. doi: 10.1111/pan.12038. Epub 2012 Oct 9.

  PMID: 23043512 BACKGROUND

• 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 DERIVED

• Frelich M, Lecbychova K, Vodicka V, Ekrtova T, Sklienka P, Jor O, Strakova H, Bilena M, Formanek M, Bursa F. Effect of BIS-guided anesthesia on emergence delirium following general anesthesia in children: A prospective randomized controlled trial. Anaesth Crit Care Pain Med. 2024 Feb;43(1):101318. doi: 10.1016/j.accpm.2023.101318. Epub 2023 Oct 31.

  PMID: 37918790 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Emergence Delirium

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michal Frelich, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is being used in this study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be randomized into two study arms.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 10, 2020
• Study Start: July 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)