- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07601698
Dexmedetomidine vs Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anasthesia
19 maj 2026 uppdaterad av: 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Beräknad)
200
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: taher mohamed, residant
- Telefonnummer: 01120799228
- E-post: taher2014mohamed@yahoo.com
Studera Kontakt Backup
- Namn: elhadad ali mousa, professor
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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-jämförare: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of emergence agitation
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to extubation
Tidsram: 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
Tidsram: 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
Tidsram: From baseline until 30 minutes postoperatively
|
Assessment of heart rate during emergence and recovery period.
|
From baseline until 30 minutes postoperatively
|
|
Postoperative pain score
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 maj 2026
Primärt slutförande (Beräknad)
30 november 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
9 maj 2026
Först inskickad som uppfyllde QC-kriterierna
19 maj 2026
Första postat (Faktisk)
22 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Mentala störningar
- Postoperativa komplikationer
- Patologiska processer
- Förvirring
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Delirium
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Emergence Delirium
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Azoler
- Kolväten
- Kolväten, cykliska
- Kolväten, aromatisk
- Imidazoler
- Fenoler
- Bensiverivat
- Dexmedetomidin
- Propofol
Andra studie-ID-nummer
- EA in sevofluran in anesthesia
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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