NCT04466579 is a NA clinical trial of BIS monitor in Postoperative Nausea, sponsored by University Hospital Ostrava.

Who is sponsoring NCT04466579?

NCT04466579 is sponsored by University Hospital Ostrava.

What drugs are being tested in NCT04466579?

Interventions in NCT04466579: BIS monitor, Standard care.

What condition does NCT04466579 study?

NCT04466579 studies Postoperative Nausea, Postoperative Vomiting, Emergence Delirium.

Is NCT04466579 still recruiting?

NCT04466579 is currently completed. Last updated 11 September 2023.

Last reviewed 2023-09-11 · How we verify

NCT04466579

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 11 September 2023

What this trial tests

NA trial testing BIS monitor in Postoperative Nausea in 100 participants. Completed in 30 June 2023.

Timeline

1 July 2020

Primary endpoint
31 May 2023

30 June 2023

Quick facts

Lead sponsor	University Hospital Ostrava
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	1 July 2020
Primary completion	31 May 2023
Estimated completion	30 June 2023
Sites	1 location across Czechia

Drugs / interventions tested

BIS monitor
Standard care — full drug profile →

Conditions studied

Postoperative Nausea — all drugs for Postoperative Nausea →
Postoperative Vomiting — all drugs for Postoperative Vomiting →
Emergence Delirium — all drugs for Emergence Delirium →

Sponsor

University Hospital Ostrava

Who can join

Adults 3 to 8, any sex, with Postoperative Nausea or Postoperative Vomiting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Effect of BIS-guided anesthesia on emergence delirium following general anesthesia in children: A prospective randomized controlled trial.
Frelich M, Lečbychová K, Vodička V, Ekrtová T, et al · · 2024 · cited 17× · PMID 37918790 · DOI 10.1016/j.accpm.2023.101318
The effect of BIS-guided anaesthesia on the incidence of postoperative nausea and vomiting in children: a prospective randomized double-blind study.
Frelich M, Sklienka P, Romanová T, Němcová S, et al · · 2024 · cited 4× · PMID 38982400 · DOI 10.1186/s12871-024-02610-w

Verify or expand the search:

Other trials of BIS monitor

Trials testing the same drug.

NCT03911544 — Bispectral Index and Surgical Field · NA · completed
NCT03453359 — Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial · NA · completed
NCT03461029 — Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies · completed

Other University Hospital Ostrava trials

Trials by the same sponsor.

NCT07177183 — Low Serum Creatinine as a Predictor of Prolonged Mechanical Ventilation and Weaning Failure · NA · recruiting
NCT07374289 — On Scene ECPR in Ostrava · NA · recruiting
NCT07041086 — Prehospital ECPR in Moravia Silesia Region · recruiting
NCT07009652 — Optimization of Transport and Use of a Mobile ECMO Team in Patients With Sudden Cardiac Arrest in the Moravian-Silesian · recruiting
NCT06921746 — Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04466579 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Ostrava
Last refreshed: 11 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04466579.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing