CompletedNot Applicable

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

Czechia100 participantsStarted 2020-07-01

Plain-language 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.

Who can participate

Age range3 Years – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 3-8 years of age * Indication for the performance of endoscopic adenoidectomy in general anesthesia * ASA I a II * Consent of a parent/a guardian Exclusion Criteria: * 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

What they're measuring

Incidence of PONV

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

Incidence of ED

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

Trial details

NCT IDNCT04466579

SponsorUniversity Hospital Ostrava

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Postoperative Nausea trials