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Dexmedetomidin und Agitation nach Nasenoperation

26. September 2026 aktualisiert von: Yasser S Mostafa, MD, Fayoum University Hospital

Wirksamkeit von Einzelbolus im Vergleich zu kontinuierlicher Infusion von Dexmedetomidin bei der Minderung der Agitation bei Erwachsenen, die sich einer Nasenoperation unterziehen: Eine prospektive randomisierte Studie

The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.

Studienübersicht

Detaillierte Beschreibung

Agitation during emergence from general anesthesia is a potentially serious phenomenon that has not been studied in adults as often as in pediatric population. When agitation, serious self-injury, or violence towards the medical team occur, with the risk of aspiration, bleeding, hypoxia, arrhythmias, or simply pulling the endotracheal tubes, removal of drains or catheters. Moreover, agitated patients are not only at risk of developing complications but also, they are labor intensive as they require more medical attention, rescue drugs, and more attending staff till agitation attack safely subside. Recognized risk factors to develop emergence agitation (EA) in adults include ear, nose, and throat surgery, obesity, sevoflurane anesthesia, endotracheal tube, and history of psychological illness. In adults, adjuvants have been co-administered with general anesthesia in order to negate or reduce the incidence of EA especially in patients with identified risk factors.

dexmedetomidine is a highly selective α2 sympatholytic, has been proposed as an attractive candidate for the prophylaxis of EA. By interacting with α2 receptors in locus coeruleus of the pons, Dex exerts its unique anxiolytic, sedative and sympathetic antagonistic action with no respiratory depression. Moreover, it has pain-modulating effect due to interaction with α2 receptor sites in the dorsal horn and supra-spinal regions.

Nevertheless, there have been conflicting data about Dex optimal dose and time of administration when used as prophylaxis against EA. Indeed, different dosing protocols are associated with over sedation, prolonged extubation time, and delayed post-anaesthesia care unit time.

No premedication. Basic general anesthesia monitoring included electrocardiogram, pulse oximetry, non-invasive arterial pressure, and capnography, were recorded every 5 min. Preoxygenation with 100% oxygen for 5 min was performed before fentanyl 1 μg/kg and propofol 1.5-2 mg/ kg, were administered as induction agents. Intubation with facilitated with atracurium besylate 0.5 mg/ kg. The size of endotracheal tubes was 6.5-7.5 mm, for females and males, respectively. Mechanical ventilation was set on 6 ml/kg tidal volume, and respiratory rate was adjusted to keep end-tidal CO2 between 35 and 40 mmHg, in 50% O2/air. All patients at induction were given dexamethasone 4 mg i.v., ondansetron, 4 mg i.v to prevent post-operative nausea and vomiting, plus Ringers lactate solution 6 mg/ kg drip for basic volume maintenance. Blood loss was compensated for with Ringers lactate, intraoperatively. Maintenance of anesthesia was carried out with Isoflurane, regulated at 2-3%, Titrated incremental doses of atropine 0.5 mg, esmolol 10 mg, and ephedrine 6 mg were given i.v., when HR ≤ 45, HR ≥ 120 and MAP ≤ 60, in the mentioned order. ketorolac 30 mg was given I.M., at the time of nasal packing.

When surgery was finished, gentle suction was attempted, non-depolarizing muscle relaxant reverse with atropine, 0.5 mg and neostigmine 0.02 mg/kg was given. Next, isoflurane was turned off and respiration was then converted back to manual ventilation with 100% oxygen at 7 L/min. The patients were not disturbed, except by continual verbal requests to open their eyes. All other stimuli were prevented. Extubation was done when patients were able to breathe spontaneously and interact with verbal demands. When patients were awake, calm, and sedated, they were transferred to the PACU. Patients were discharged from the PACU when their Aldrete score was ≥ 9.

Statistical analysis:

Statistical analysis will be conducted using IBM SPSS Statistics 22 (IBM Corporation, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p < 0.05 will be deemed to be statistically significant.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Faiyum Governorate
      • Al Fayyum, Faiyum Governorate, Ägypten, 63514
        • Rekrutierung
        • Fayoum University Hospital
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) Ⅰ or II
  • Adults with body mass index (BMI) < 30 Kg/m
  • Underwent elective nasal surgery.

Exclusion Criteria:

  • Significant comorbidity like hepatic, renal, or cardiac disease
  • Auditory impairment
  • Cognitive dysfunction
  • Substance abuse
  • Allergy to the studied medicines
  • Planned intensive care admission after the surgery.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Bolus group

single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery

An infusion given all through intraoperative time

Andere Namen:
  • Dexmedetomidin-Infusion
Experimental: Infusion group

Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time

Single dose given 15 minutes before end of surgery

Andere Namen:
  • Dexmedetomidin Bolus

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)
Zeitfenster: 5 minutes after operation

RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation

5 minutes after operation

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intraoperative heart rate
Zeitfenster: Every 15 minutes along operation

Beats / minute

Every 15 minutes along operation
Intraoperative mean arterial blood pressure
Zeitfenster: Every 15 minutes along operation

mmHg

Every 15 minutes along operation
Time of first rescue analgesic
Zeitfenster: 5 minutes before first analgesic request

in minutes in minutes

5 minutes before first analgesic request
Extubation time
Zeitfenster: 3 minutes after removal of endotracheal tube

time interval between shutting off anesthetics to extubation (in minutes)

3 minutes after removal of endotracheal tube
Postanesthesia care unit time
Zeitfenster: 5 minutes after discharge from recovery unit

time interval from admission to PACU till patient scored ≥ 9 on Aldrete scale (ready to discharge)

5 minutes after discharge from recovery unit
Incidence of use of midazolam
Zeitfenster: 2 minutes after occurence of emergence agitation

Yes or no

2 minutes after occurence of emergence agitation
Numerical rating score (NRS)
Zeitfenster: Every 10 min in postanesthesia care unit

10 point scale where zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Every 10 min in postanesthesia care unit
Total amount of rescue analgesic
Zeitfenster: 24 hours postoperative

in milligram

24 hours postoperative
Boezaart Surgical Field Grading Scale
Zeitfenster: 2 hours intraoperatively

endoscopically using the six-point score (0-5 Scale) where 0 - No bleeding, 1 - Slight bleeding, no suctioning needed, 2 - Slight bleeding, occasional suctioning needed, 3 - Moderate bleeding, frequent suctioning needed, visibility maintained, 4 - Heavy bleeding, constant suctioning needed, visibility impaired, 5 - Severe bleeding, uncontrolled, surgery impossible

2 hours intraoperatively
Incidence of bradycardia
Zeitfenster: 2 hours intraoperatively

Yes or no

2 hours intraoperatively
Incidence of hypotension
Zeitfenster: 2 hours intraoperatively

Yes or no when mean arterial blood pressure below 60 mmHg

2 hours intraoperatively
Incidence of nausea
Zeitfenster: 24 hours postoperative

Yes or no

24 hours postoperative
Incidence of vomiting
Zeitfenster: 24 hours postoperative

Yes or no

24 hours postoperative

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Age
Zeitfenster: 5 minutes before entering operation department

in years

5 minutes before entering operation department
Sex
Zeitfenster: 5 minutes before entering operation department

Male of female

5 minutes before entering operation department
Weight
Zeitfenster: 5 minutes before entering operation department

In kilogram

5 minutes before entering operation department
Height
Zeitfenster: 5 minutes before entering operation department

In centimeter

5 minutes before entering operation department
Duration of surgery
Zeitfenster: 5 minutes after end of surgery

In minutes

5 minutes after end of surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Yasser S Mostafa, MD, Fayoum University
  • Studienstuhl: Mohamed A Shawky, MD, Fayoum University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2025

Primärer Abschluss (Geschätzt)

1. November 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

4. März 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. März 2025

Zuerst gepostet (Tatsächlich)

10. März 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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