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The association between dexmedetomidine use in pediatric propofol-rufinorexia general anesthesia and the quality of early postoperative recovery: A prospective cohort study

The association between dexmedetomidine use in pediatric propofol-rufinorexia general anesthesia and the quality of early postoperative recovery: A prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123408
Enrollment
Unknown
Registered
2026-04-26
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The agitation during the awakening period of children

Interventions

Exposure group (Dexmedetomidine):None
Non-exposed group:None

Sponsors

Liuzhou people's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age: 2-12 years old (calculated based on birthday), covering early childhood to school age to assess recovery differences at different stages of development. 2. ASA grade: Grade I (healthy patients) or Grade II (mild systemic disease with no functional limitations, such as well-controlled asthma or mild obesity). 3. Type of surgery: Elective surgery, expected to last 30-120 minutes, such as inguinal hernia repair, circumcision, tonsillectomy, or minor ENT surgery, which are common in children and have a low risk of anesthesia. 4. Cooperative ability: The child can basically cooperate with medical procedures (such as through games or communication assessments) in the preoperative evaluation, or the parent/guardian can provide reliable information. 5. Informed consent: Written informed consent signed by parents or legal guardians; for children aged 8 years and older, additional informed consent from the child shall be obtained, using age-appropriate explanations for informed information.

Exclusion criteria

Exclusion criteria: 1. Drug allergy: Known history of allergic reaction to dexmedetomidine, propofol, remifentanil, sufentanil or related drugs. 2. Severe comorbidities: including cardiovascular disease (such as congenital heart disease, heart failure), respiratory disease (such as uncontrolled asthma, sleep apnea), liver or kidney insufficiency. 3. Neurological or psychiatric disorders: such as epilepsy, cerebral palsy, developmental delay, or autism spectrum disorder, which may affect the assessment of recovery quality. 4. History of drug use: Use of central nervous system drugs (such as benzodiazepines, antidepressants, opioids) within 1 month before surgery to avoid interactions. 5. Anesthesia risk factors: expected difficult airway (Mallampati score grade III-IV), morbid obesity (body mass index >95th percentile for the same age), or excessive surgical complexity (such as cardiothoracic surgery), or postoperative need for ICU monitoring, etc. 6. Others: Recent (within 3 months) participation in other clinical trials, or parents/guardians unable to cooperate with follow-up.

Design outcomes

Primary

MeasureTime frame
FLACC score;The duration of stay in the PACU (Post-Anesthesia Care Unit);PAED score;PedSQoR score;The time of awakening;

Secondary

MeasureTime frame
Incidence rate of adverse events (such as bradycardia);The incidence rate of PONV;The first time requesting pain medication;Total dosage of analgesics;

Countries

China

Contacts

Public ContactYu Xiangdi

Liuzhou people's hospital

Xiangdi_Yu@163.com+86 772 266 2566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026