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Postoperative NauseaNCT04466579

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

A study testing BIS monitor in people with Postoperative Nausea and Postoperative Vomiting, run by University Hospital Ostrava at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 8 years
What is being tested?
BIS monitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCzechia
Study dates
1 Jul 2020to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

Other trials in Czechia

About this study

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.

Read the detailed description

The condition of postoperative nausea and vomiting (PONV) is defined as nausea and vomiting, which appears within 24 hours after the performance of a surgical/diagnostic procedure in general anesthesia. PONV is perceived as a complication of minor importance in perioperative medicine, nevertheless, it is one of the most frequent causes of morbidity in pediatric patients in the early postoperative period, associated with a number of adverse effects. The incidence of PONV in pediatric age is reported in scientific literature to be between 8.9 and 42 percent. The pathogenesis of PONV is complex and has not been fully clarified yet. The development of PONV depends on individual and anaesthesiology risk factors, and the type of surgical procedure. The use of inhalation anesthetics demonstrably increases the incidence of PONV, especially in the course of the first two hours after the procedure. The need for inhalation anesthetic is individually variable, and it is not possible to empirically define, which dose will lead to an adequate depth of anesthesia. Excessively deep, as well as too shallow anesthesia may result in increasing the incidence of postoperative complications, including PONV. The depth of anesthesia and unconsciousness may be monitored with BIS (bispectral index). The investigators presume that optimization of the supply of inhalation anesthetic according to BIS, so-called BIGA (Bispectral index guided anesthesia) will lead to decreasing the incidence of PONV.

Several clinical studies performed on the adult population have demonstrated that using BIGA leads to a decreased incidence of PONV in adult patients undergoing gynecological procedures. As far as pediatric anesthesiology is concerned, similar studies are still lacking.

Inhalation anesthesia is also associated with another complication in the early postoperative period - so-called emergence delirium (ED). It is a condition of psychomotor restlessness, perception disorders, and excitation of the child observed after completion of anesthesia. The incidence of ED in the pediatric population anesthesia is between 10 and 80 percent, most frequently within the first 10-30 minutes after discontinuation of the administration of anesthetics. The condition is characterized by confusion, loss of orientation, crying, restlessness, and non-cooperation of the child. The causes of ED have not been fully clarified.

One of the possible causes may be the rapid emergence of the child from anesthesia after discontinuation of the inhalation anesthetic. The incidence of ED is highest with Sevoflurane, which is the most frequently used inhalation anesthetic in pediatric anesthesia. Optimization of the depth of general anesthesia and decreasing the consumption of inhalation anesthetic may lead to decreasing the incidence of emergence delirium objectified according to the Paediatric Anaesthesia Emergence Delirium (PAED) score.

The study has been designed as a prospective randomized clinical trial. Due to the use of the 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) of 1.0). The target values of the depth of general anesthesia according to BIS are between 40 and 60.

General anesthesia will be administered according to the following uniform anaesthesiology protocol:

Inhalation introduction with Sevoflurane (8% on the vaporizer), in a carrier mixture of gases oxygen : air, with the flow of 41/min and oxygen concentration of 50%. In the intervention group, BIS will be introduced as soon as possible. After achieving a sufficient depth of anesthesia, a peripheral venous catheter will be introduced, followed with intravenous administration of opioid - Sufentanil in the dose of 0.2ucg/kg, and intravenous administration of Paracetamol in the dose of 15mg/kg. The infusion will be administered in the course of the surgical procedure - isotonic crystalloid solution Benelyte in the dose of 10ml/kg/hour. Breathing passageways will be secured with an armed laryngeal mask, according to the standard procedure applied at the author's center. Considering the character of the study, no antiemetic prophylaxis will be administered. After completion of the surgical procedure and emergence from general anesthesia, the child will be transferred to post-anesthesia care unit (PACU), where, apart from the monitoring of vital functions, also the incidence of PONV and the PAED score (in the 10th minute, 30th minute, and 60th minute) will be observed. At the Ear-Nose-Throat (ENT) department, the authors will record the Baxter Retching Faces (BARF) scale in pre-determined time intervals, and the incidence of PONV in the course of the whole hospitalization.

Being tested
BIS monitor, Standard care
Keywords
postoperative nausea, postoperative vomiting, emergence delirium, bispectral monitor, pediatric anesthesia, adenoidectomy, general anesthesia
Medical subject headings
Postoperative Nausea and Vomiting, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04466579
Study groupRoleWhat they receive
BIS monitoringExperimentalStudy subjects randomized in this study arm will have the depth of anesthesia controlled with the BIS monitor.
Receives: Other: BIS monitor
Standard careActive comparatorStudy subjects randomized in this study arm will receive standard anesthesiology care according to the usual procedures used at the study centre.
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Incidence of ED

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start1 Jul 2020
  3. Primary completion31 May 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study subjects will be randomized into two study arms.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04466579
Sponsor's protocol ID
FNO-KARIM-14-PONV-ED
Status last verified
Sep 2023
First submitted
24 Jun 2020
Last updated
11 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The authors have no plan to make individual participant data available to other researchers. The data may be provided upon request.

Publications

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

    PubMed 17291136
  • 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.

    PubMed 24356162
  • 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.

    PubMed 10485781
  • 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.

    PubMed 24784918
  • 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.

    PubMed 23043512
  • 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.

    PubMed 38982400
  • 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.

    PubMed 37918790

Questions about this trial

What is this clinical trial studying?

A study testing BIS monitor in people with Postoperative Nausea and Postoperative Vomiting, run by University Hospital Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of PONV (time frame: During the hospitalisation of the patient, i.e. up to 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466579, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.

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