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DexMedetomidine en agitatie na nasale chirurgie

26 september 2026 bijgewerkt door: Yasser S Mostafa, MD, Fayoum University Hospital

Effectiviteit van enkele bolus versus continue infusie van dexmedetomidine bij het verzachten van agitatie bij volwassenen die een nasale chirurgie ondergaan: een prospectieve gerandomiseerde 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Faiyum Governorate
      • Al Fayyum, Faiyum Governorate, Egypte, 63514
        • Werving
        • Fayoum University Hospital
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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:
  • Dexmedetomidine-infusie
Experimenteel: 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:
  • DexMedetomidine Bolus

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intraoperative heart rate
Tijdsspanne: Every 15 minutes along operation

Beats / minute

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

mmHg

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

in minutes in minutes

5 minutes before first analgesic request
Extubation time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 2 minutes after occurence of emergence agitation

Yes or no

2 minutes after occurence of emergence agitation
Numerical rating score (NRS)
Tijdsspanne: 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
Tijdsspanne: 24 hours postoperative

in milligram

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

Yes or no

2 hours intraoperatively
Incidence of hypotension
Tijdsspanne: 2 hours intraoperatively

Yes or no when mean arterial blood pressure below 60 mmHg

2 hours intraoperatively
Incidence of nausea
Tijdsspanne: 24 hours postoperative

Yes or no

24 hours postoperative
Incidence of vomiting
Tijdsspanne: 24 hours postoperative

Yes or no

24 hours postoperative

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Age
Tijdsspanne: 5 minutes before entering operation department

in years

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

Male of female

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

In kilogram

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

In centimeter

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

In minutes

5 minutes after end of surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Yasser S Mostafa, MD, Fayoum University
  • Studie stoel: Mohamed A Shawky, MD, Fayoum University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2025

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

4 maart 2025

Eerst ingediend dat voldeed aan de QC-criteria

5 maart 2025

Eerst geplaatst (Werkelijk)

10 maart 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

26 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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