Actively Recruiting
Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries: A Randomized Controlled Study.
Led by Cairo University · Updated on 2024-08-20
46
Participants Needed
2
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of ketofol compared to dexmedetomidine for preventing emergence delirium in children aged 2 to 6 years undergoing squint surgery. This prospective randomized controlled double-blinded study aims to compare the incidence of emergence delirium (ED) and assess the side effects of both drugs on heart rate, blood pressure, recovery time, nausea, and vomiting. The study is conducted at Specialized Children Hospital, Cairo University, with ethical approval and informed consent from parents. Participants are randomly assigned to one of two groups: one group receives dexmedetomidine infusion at 0.2 mcg/kg/hr starting five minutes after securing the airway, while the other group receives ketofol (a mixture of ketamine and propofol in a 1:4 ratio) infusion at 0.6 ml/kg/hr starting five minutes after induction. Standard anesthesia and surgical procedures are followed, including monitoring vital signs and administering premedications. Infusions are stopped ten minutes before surgery ends, and patients receive paracetamol for pain relief. After surgery, patients are extubated and moved to the post-anesthesia care unit (PACU). During their PACU stay, children are closely monitored for delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale at multiple intervals up to 30 minutes after extubation. Pain is assessed with the FLACC scale, and rescue sedation or analgesia is given as needed. Vital signs and possible complications like bradycardia or hypotension are recorded throughout. The study measures the incidence of ED on arrival at PACU as the primary outcome, along with secondary outcomes including intraoperative and postoperative vital signs, sedation and analgesia usage, nausea, vomiting, and PACU stay duration.
CONDITIONS
Brief Title
Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 2 to 6 years
- Both sexes
- ASA physical status I or II
- Scheduled for squint surgery
You will not qualify if you...
- Refusal of parents to consent
- Sensitivity or allergy to ketamine, propofol, or dexmedetomidine
- Known neurological disease affecting postoperative delirium assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for preoperative checkup and eligibility assessment
Duration - Duration of the surgical procedure (typically a few hours)
Participants receive anesthesia for squint surgery with continuous infusion of either Ketofol or Dexmedetomidine during surgery.
1 visit (in-person) on the day of surgery including preoperative preparation, surgery, and anesthesia administration
Duration - Up to several hours until discharge from PACU
Participants are monitored in the post-anesthesia care unit (PACU) where emergence delirium and other postoperative parameters are assessed until discharge criteria are met.
Continuous monitoring with assessments at 5, 10, 15, 20, 25, and 30 minutes after extubation until discharge
Trial Site Locations
Total: 2 locations
1
Abu Elresh Hospitals ( Cairo university )
Cairo, Egypt
Actively Recruiting
2
Abu ElResh hospital
Cairo, Egypt
Not Yet Recruiting
Research Team
M
Muhammad Kh Ibrahim
M
Mohamed El Abdelfatah
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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