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Preemptiv intravenøs mikrodose deksmedetomidin for å forebygge oppvåkningagitasjon hos voksne pasienter som gjennomgår septumplastikk-operasjoner

5. oktober 2026 oppdatert av: Mai Salah Salem, Tanta University

Forebyggende intravenøs mikrodose Dexmedetomidin for å forebygge oppvåkningsopphisselse hos voksne pasienter som gjennomgår septumplastikk-operasjoner: En randomisert placebokontrollert studie

This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Emergence agitation (EA) is characterised by confusion, restlessness or aggressive behaviour during recovery from general anaesthesia. EA is more common following ear, nose, & throat (ENT) surgery. The exact cause and pathophysiology of EA are unknown, although risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, otolaryngology operations, and the use of inhalational anesthetics particularly sevoflurane. EA might cause injury, accidental removal of intravenous cannulation, self-extubation, post-operative wound bleeding and increase the nursing requirements in the post-anesthesia care unit (PACU). There are limited studies concerning adult EA, and although its prevalence is less than child EA, it carries more risk of injury due to serious uncontrolled behaviors. Intravenous (IV) anesthetics, sedatives and opioids are the most frequently utilized medications to manage EA, with variable success rates and significant potential to delay recovery and cause undesirable side-effects. Dexmedetomidine is a highly selective α2 agonist which produces sedation and anxiolysis through reduction in sympathetic central nervous system activity. It has a major advantage over other sedatives; it is associated with minimal respiratory depression. According to a recent meta-analysis, intraoperative administration of dexmedetomidine decreases postoperative pain and the incidence of EA in adults. Considering the short length of corrective nasal reduction surgery (CR), an intraoperative infusion of dexmedetomidine as an anesthetic adjuvant may prolong the anesthesia and recovery time. Low dose infusion of dexmedetomidine (0.2 µg /kg/h) has been reported to reduce incidence of EA and opioid consumption effectively in elderly patients undergoing cancer surgeries under GA. Previous studies have shown that a single dose of dexmedetomidine, not as a premedication, is also effective in reducing EA and facilitating smooth extubation after pediatric adenotonsillectomy. Also recent study reported the efficacy of pre-operative dexmedetomidine administration (1 μg/kg) in preventing EA in adults undergoing CR of a nasal bone fracture. Up till now no clinical studies investigated the efficacy of single pre-operative micro dose of dexmedetomidine in prevention of EA, so in this clinical study we hypothesize that preoperative micro dose of dexmedetomidine may be beneficial in mitigation of EA in short timed Septoplasty surgeries safely and without prolongation of recovery time.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31527
        • Tanta university

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Adult patients of both gender aged 18 to 60 years with American Society of Anesthesiologists (ASA) Physical Status I or II, who were scheduled for septoplasty surgery under general anesthesia.

Exclusion Criteria:

  • Patients declined to participate in the trial.
  • History or clinical evidence of chronic obstructive pulmonary disease.
  • History of renal or hepatic dysfunction, sleep apnea syndrome.
  • Cognitive dysfunction or psychiatric disorder.
  • Patients receiving beta blocker.
  • Patients with anticipated difficult airway.
  • Patients with electro cardiac abnormalities.
  • Emergency surgeries.
  • Pregnancy.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dexmedetomidine group

60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Placebo komparator: Control group

60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of emergence agitation
Tidsramme: incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

using Aono's Four-Point Scale (Aono Scale) which is a simple and widely used tool to assess emergence agitation (EA). It categorizes agitation during emergence from anesthesia into four levels.

  1. calm_ Patient is quiet and not agitated.
  2. Not calm but can be easily consoled _ Slight restlessness but settles with verbal reassurance or mild physical comfort.
  3. Moderately agitated _ Patient is crying or difficult to console but not combative.
  4. Severely agitated _Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

Scores 3-4 indicate clinically relevant emergence agitation.

incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
severity of emergence agitation
Tidsramme: severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

Aono's Scale grades the intensity of a patient's agitation during emergence from anesthesia (3) Moderately agitated - Patient is crying or difficult to console but not combative.

(4) Severely agitated - Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.
extubation time
Tidsramme: Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).
Length of stay in the post anesthetic care unit (PACU).
Tidsramme: time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

Total time a patient spends in the PACU from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward
Intraoperative opioid consumption
Tidsramme: from induction of anesthesia until completion of surgery

Total amount of opioid medications administered to a patient during the entire surgical procedure, from induction of anesthesia until completion of surgery

from induction of anesthesia until completion of surgery
Post operative numerical rating scale score (NRS)
Tidsramme: - NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery

The Numerical Rating Scale (NRS) is a validated tool used to assess a patient's pain intensity by having them assign a number to their pain on a 0-10 scale.

On a scale from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable

- NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. januar 2026

Primær fullføring (Faktiske)

20. august 2026

Studiet fullført (Faktiske)

20. august 2026

Datoer for studieregistrering

Først innsendt

11. desember 2025

Først innsendt som oppfylte QC-kriteriene

11. desember 2025

Først lagt ut (Faktiske)

24. desember 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2026

Sist bekreftet

1. desember 2025

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author

IPD-delingstidsramme

The data will be available upon a reasonable request from the corresponding author after the end of the study for one year

Tilgangskriterier for IPD-deling

The data will be available upon a reasonable request from the corresponding author

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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