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Dexmedetomidina e agitazione dopo chirurgia nasale

26 settembre 2026 aggiornato da: Yasser S Mostafa, MD, Fayoum University Hospital

Efficacia del singolo bolo rispetto all'infusione continua di dexmedetomidina nella mitigazione dell'agitazione negli adulti sottoposti a chirurgia nasale: uno studio prospettico randomizzato

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Faiyum Governorate
      • Al Fayyum, Faiyum Governorate, Egitto, 63514
        • Reclutamento
        • Fayoum University Hospital
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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

Altri nomi:
  • Infusione di dexmedetomidina
Sperimentale: 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

Altri nomi:
  • Dexmedetomidine bolo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intraoperative heart rate
Lasso di tempo: Every 15 minutes along operation

Beats / minute

Every 15 minutes along operation
Intraoperative mean arterial blood pressure
Lasso di tempo: Every 15 minutes along operation

mmHg

Every 15 minutes along operation
Time of first rescue analgesic
Lasso di tempo: 5 minutes before first analgesic request

in minutes in minutes

5 minutes before first analgesic request
Extubation time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 2 minutes after occurence of emergence agitation

Yes or no

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

in milligram

24 hours postoperative
Boezaart Surgical Field Grading Scale
Lasso di tempo: 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
Lasso di tempo: 2 hours intraoperatively

Yes or no

2 hours intraoperatively
Incidence of hypotension
Lasso di tempo: 2 hours intraoperatively

Yes or no when mean arterial blood pressure below 60 mmHg

2 hours intraoperatively
Incidence of nausea
Lasso di tempo: 24 hours postoperative

Yes or no

24 hours postoperative
Incidence of vomiting
Lasso di tempo: 24 hours postoperative

Yes or no

24 hours postoperative

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Age
Lasso di tempo: 5 minutes before entering operation department

in years

5 minutes before entering operation department
Sex
Lasso di tempo: 5 minutes before entering operation department

Male of female

5 minutes before entering operation department
Weight
Lasso di tempo: 5 minutes before entering operation department

In kilogram

5 minutes before entering operation department
Height
Lasso di tempo: 5 minutes before entering operation department

In centimeter

5 minutes before entering operation department
Duration of surgery
Lasso di tempo: 5 minutes after end of surgery

In minutes

5 minutes after end of surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Yasser S Mostafa, MD, Fayoum University
  • Cattedra di studio: Mohamed A Shawky, MD, Fayoum University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2025

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

4 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

5 marzo 2025

Primo Inserito (Effettivo)

10 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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