- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07601698
Dexmedetomidine vs Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anasthesia
19. maj 2026 opdateret af: Taher Mohamed Aboelyamin, Sohag University
The Efficacy of Dexmedetomidine Versus Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anesthesia in Pediatric Ophthalmic Surgeries , A Prospective Randomized Comparative Controlled Study
Primary we will Compare the Efficacy between Dexmedetomidine and "Propofol-lidocaine" mixture in preventing the post operative emergence agitation following sevoflurane anasthesia in pediatric ophthalmic surgeries Secondary we will evaluate time of extubation, time of orientation, Hemodynamic variables, Visual analog scale ( VAS), facial expressions scale , Adverse events
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Emergence agitation (EA) is a frequent and distressing complication in pediatric anesthesia, particularly following the use of volatile agents such as sevoflurane.
It is characterized by restlessness, inconsolable crying, disorientation, and incongruent behavior during the early recovery period from general anesthesia (Dahmani S et al.,2014 ).
Although EA is usually self-limited, it may cause harm to patients by leading to self-injury, disruption of surgical sites, removal of intravenous lines, or increased stress for caregivers and healthcare providers.
The reported incidence of EA in children ranges between 10% and 80%, with higher prevalence observed in younger patients and in ophthalmic surgeries due to sensory deprivation and postoperative discomfort (Dahmani S et al.,2014 ).
Sevoflurane remains the most widely used inhalational agent in pediatric anesthesia because of its rapid induction, low airway irritability, and favorable hemodynamic profile.
However, it has been consistently associated with a higher risk of EA compared with other anesthetic techniques (Zhang Y et al., 2022) - (Liu J et al., 2022).
Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has emerged as a promising agent due to its sedative, analgesic, and anxiolytic properties without significant respiratory depression (Zhang Y et al., 2022) - (Liu J et al., 2022).
Several studies have demonstrated its efficacy in reducing the incidence and severity of EA when administered perioperatively (Zhang Y et al., 2022)- (Abdel-Ghaffar HS et al., 2019).
On the other hand, propofol, a short-acting intravenous anesthetic with sedative and antiemetic properties, has also been investigated for EA prevention.
When combined with lidocaine, propofol infusion provides not only smooth sedation and rapid recovery but also decreases pain associated with injection and potentially modulates airway reflexes and emergence agitation (Kim YH et al., 2014).
Previous studies have shown that a single bolus dose of propofol at the end of surgery can reduce EA incidence in children undergoing ophthalmic surgery (Aouad MT t al., 2007).
Meta-analyses further confirmed the beneficial role of propofol in reducing EA and improving recovery profiles (Liu J et al.,2022) -(Li Y et al.,2019).
In ophthalmic surgeries for young children, smooth emergence from anesthesia is crucial, as agitation can compromise surgical outcomes, increase the risk of complications, and delay recovery (Kim YH et al., 2014)- (Aouad MT t al., 2007).
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: taher mohamed, residant
- Telefonnummer: 01120799228
- E-mail: taher2014mohamed@yahoo.com
Undersøgelse Kontakt Backup
- Navn: elhadad ali mousa, professor
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- patients aged 2-8 years .
- ASA physical status I-II.
- Scheduled for elective surgeries under general anesthesia with sevoflurane
Exclusion Criteria:
- History of psychiatric illness or cognitive impairment.
- Known allergy to study drugs.
- Severe cardiovascular, hepatic, or renal disease.
- Chronic use of sedatives or opioids.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: dexmedetomidine
Dexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery
|
Dexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery
|
|
Eksperimentel: Propofol plus lidocaine
Propofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery
|
Propofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery.
|
|
Placebo komparator: placebo
receive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery
|
receive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of emergence agitation
Tidsramme: Assessed at 5, 10, 15, and 30 minutes after extubation in the post-anesthesia care unit (PACU)
|
Incidence of emergence agitation assessed using Aono's Four-Point Scale after extubation in pediatric patients undergoing ophthalmic surgery under sevoflurane anesthesia.
|
Assessed at 5, 10, 15, and 30 minutes after extubation in the post-anesthesia care unit (PACU)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to extubation
Tidsramme: From discontinuation of anesthesia until extubation, up to 30 minutes
|
The interval between discontinuation of anesthetic agents and successful extubation.
|
From discontinuation of anesthesia until extubation, up to 30 minutes
|
|
Time to orientation
Tidsramme: During recovery period in PACU, up to 30 minutes postoperatively
|
The interval between discontinuation of anesthetic agents and recovery of adequate consciousness to follow simple commands.
|
During recovery period in PACU, up to 30 minutes postoperatively
|
|
Hemodynamic variables
Tidsramme: From baseline until 30 minutes postoperatively
|
Assessment of heart rate during emergence and recovery period.
|
From baseline until 30 minutes postoperatively
|
|
Postoperative pain score
Tidsramme: During the first 4 postoperative hours
|
Assessment of postoperative pain using Wong-Baker FACES scale according to patient age.
|
During the first 4 postoperative hours
|
|
Adverse events
Tidsramme: During surgery and within the first 24 postoperative hours
|
Incidence of adverse events including bradycardia, hypotension, nausea, vomiting, respiratory depression, and postoperative nausea and vomiting.
|
During surgery and within the first 24 postoperative hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. maj 2026
Primær færdiggørelse (Anslået)
30. november 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
9. maj 2026
Først indsendt, der opfyldte QC-kriterier
19. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Psykiske lidelser
- Postoperative komplikationer
- Patologiske processer
- Forvirring
- Neuroadfærdsmæssige manifestationer
- Neurokognitive lidelser
- Delirium
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Emergence Delirium
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Azoler
- Kulbrinter
- Kulbrinter, cyklisk
- Kulbrinter, aromatisk
- Imidazoler
- Fenoler
- Benzenderivater
- Dexmedetomidin
- Propofol
Andre undersøgelses-id-numre
- EA in sevofluran in anesthesia
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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Kliniske forsøg med Emergence Agitation
-
BioXcel Therapeutics IncCognitive Research CorporationAfsluttetManiodepressiv | Agitation, psykomotorisk | Agitation forbundet med bipolar lidelseForenede Stater
-
Impel PharmaceuticalsAfsluttet
-
Hennepin Healthcare Research InstituteAfsluttetAgitation, psykomotoriskForenede Stater
-
Prince of Songkla UniversityAfsluttetEmergence agitation, postoperative adfærdsændringerThailand
-
Bionomics LimitedAfsluttet
-
Tehran University of Medical SciencesAfsluttetKetamin-induceret agitationIran, Islamisk Republik
-
Istanbul Medeniyet UniversityUkendtAgitation på genopretning fra sedation
-
Qilu Pharmaceutical Co., Ltd.Ikke rekrutterer endnu
-
Hennepin Healthcare Research InstituteAfsluttet
-
Third Affiliated Hospital, Sun Yat-Sen UniversityUkendtPostoperativ agitation af patienterKina
Kliniske forsøg med Dexmedetomidine
-
Bahria International HospitalAfsluttet
-
Cairo UniversityRekrutteringBupivacain | Intratekal dexmedetomidin | Knæ-ortopædisk kirurgiEgypten
-
Peking University First HospitalRekrutteringDelirium | Dexmedetomidin | Postoperativ pleje | Intensivafdeling | Ældre patienter | EsketaminKina
-
Indonesia UniversityAfsluttetKnækirurgi | Bækkenkirurgi | Spinal anæstesiIndonesien
-
McGill University Health Centre/Research Institute...RekrutteringAnalgesi | Smerter, Akut | Nerveblok | Øvre ekstremitetskirurgiCanada
-
Benha UniversityRekrutteringDelirium - PostoperativtEgypten
-
Al-Azhar UniversityBenha UniversityIkke rekrutterer endnuPost-spinal rystenEgypten
-
Younes Ahmed YounesIkke rekrutterer endnu
-
Sichuan Academy of Medical SciencesIkke rekrutterer endnuSepsis | Septisk chok
-
Cairo UniversityUkendtSpinal anæstesi VarighedEgypten