The effect of propofol and ketofol on restlessness after anesthesia in childre
Phase 2
Recruiting
- Conditions
- Cleft palate.Cleft palate, unspecifiedQ35.9
- Registration Number
- IRCT20200825048515N22
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
Aged 6 to18 months
Candidate for cleft palate surgery
Classified as ASA I and II based on American Society of Anesthesiologists Classification
Consent to participate in the study
Exclusion Criteria
Underlying diseases such as mitochondrial metabolic disorders and fat metabolism disorders
History of convulsion
Growth and development retardation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delirium score. Timepoint: Immediately upon entering the recovery ward and 15, 30 and 45 minutes later in the recovery. Method of measurement: Pediatric Anesthesia Emergence Delirium Scale (PAED).;Pain score. Timepoint: 15, 30 and 45 minutes later in the recovery. Method of measurement: Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC).;Blood Pressure. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.;Heart rate. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.;Percentage of oxygen saturation. Timepoint: Immediately after surgery, in the minutes of 15, 30 and 45 during surgery and immediately, 15, 30 and 45 minutes after recovery. Method of measurement: Monitoring device.
- Secondary Outcome Measures
Name Time Method