Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium
- Conditions
- Comparison of the Effects of Propofol and Nasal Dexmedetomidine
- Interventions
- Registration Number
- NCT06466915
- Lead Sponsor
- Baskent University Ankara Hospital
- Brief Summary
Dental pain and anxiety are quite common in pediatric patients. However, due to children's inability to express their fears and lack of knowledge about the procedures to be performed, these symptoms have often been misunderstood and inadequately treated in pediatric settings. Children have consistently experienced high rates of emergence anxiety during the recovery process after general anesthesia. Emergence anxiety can be harmful to the patient, leading to bleeding at the surgical site, displacement of intravenous catheters, parental anxiety, additional care needs, and delays in hospital discharge. Inhalation anesthetics are preferred for pediatric surgeries because they promote faster recovery. However, inhalation anesthetics often lead to a high rate of emergence anxiety, ranging from 25% to 80% depending on the scoring scale used, the child's age, and the type of surgery performed. Additional sedative or analgesic drugs, such as midazolam, dexmedetomidine, or propofol, have been used to prevent emergence anxiety.
Dexmedetomidine is a selective α2-agonist with sedative and analgesic effects, but it can cause mild respiratory depression. Numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs. It has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression. However, although intranasal dexmedetomidine initially has relatively rapid absorption, the absorption process may take longer compared to intravenous administration, implying that the child's hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety.
The aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- ASA 1-2
- Cardiac disease,
- Psychiatric disease,
- Coronary artery disease,
- Long-term sedative drug use,
- Pulmonary disease,
- Known allergy to planned drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group PoDex Propofol Group PoDex received 0.5 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended and 0.5 mg/kg propofol IV before the extubation. Group Dex Dexmedetomidine Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended. Group Pofol Propofol Group Pofol received 1 mg/kg propofol IV before the extubation. Group PoDex Dexmedetomidine Group PoDex received 0.5 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended and 0.5 mg/kg propofol IV before the extubation.
- Primary Outcome Measures
Name Time Method Agitation-Delirium 0, 5, 10, 15, 20, 25, 30. minutes after extubation. It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale.
Behavioral pain assessment 0, 5, 10, 15, 20, 25, 30. minutes after extubation. It will be evaluated with a The Face, Legs, Activity, Cry, and Consolability Scale.
- Secondary Outcome Measures
Name Time Method Nausea-vomiting 0, 5, 10, 15, 20, 25, 30. minutes after extubation. It will be evaluated by visual analogue scale.
Rapid recovery 30 minutes after extubation. It will be evaluated with a Modified Aldrete Score.
Trial Locations
- Locations (1)
Ahmed Uslu
🇹🇷Ankara, Çankaya, Turkey