N/A
N=121
Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia
Emergence Delirium
Bottom Line
View on ClinicalTrials.gov: NCT06482125 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Emergence Agitation — 3.9; 2.5 Score on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexmedetomidine (Drug); Sevoflurane (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pelita Harapan University
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emergence Agitation |
3.9; 2.5 | 0.001 sig |
| PRIMARY Duration of Anesthesia (Minutes) |
50; 46 | 0.345 |
| PRIMARY Duration of Surgery (Minutes) |
41; 39 | 0.450 |
| SECONDARY Time to Extubation (Minutes) |
9.5; 10.4 | 0.356 |
| SECONDARY Time to Full Recovery |
51.7; 59.9 | 0.07 |
Summary
Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia.
Eligibility Criteria
Inclusion Criteria
- Patients with weight ranging 5 kg - 25 kg
- Patients with American Society of Anesthesiologist (ASA) Physical Status Classification 1 and 2
Exclusion Criteria
- Patients with any acquired congenital syndrome
- Patients who are actively taking anti-seizure medications and/or has been diagnosed with epilepsy
- Patients with functional and structural abnormalities of the heart, including arrythmias
- Patients with liver disease
Data sourced from ClinicalTrials.gov (NCT06482125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.