CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
BIS monitor +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04466579
NCT04466579N/ACompleted
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Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Undergoing Endoscopic Adenoidectomy in General Anesthesia

University Hospital Ostrava·interventional·Posted Jul 10, 2020·Updated Sep 11, 2023

In Brief

A clinical study evaluating BIS monitor and Standard care for Postoperative Nausea and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Nausea, Postoperative Vomiting, Emergence Delirium
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 10, 2020
Enrollment StartJul 1, 2020
Primary CompletionMay 31, 2023
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.0 years ago

Interventions

BIS monitorother

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

Standard careother

Standard anesthesiology care according to the protocol of the study