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Effect of Nebulized Dexmedetomidine and Lidocaine for Premedication on the Occurrence of Perioperative Respiratory Adverse Events in Children Undergoing Tonsillectomy:A Randomized Controlled Trial

Effect of Nebulized Dexmedetomidine and Lidocaine for Premedication on the Occurrence of Perioperative Respiratory Adverse Events in Children Undergoing Tonsillectomy:A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128417
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-07-23
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

None

Interventions

Experimental Group:Nebulized dexmedetomidine (2 µg/kg) plus 2% lidocaine, total volume 4 mL
Control Group:Nebulized 4 mL normal saline

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age 3-12 years old; 2. Elective tonsillectomy, with or without adenoidectomy; 3. ASA classification I or II; 4. The child's legal guardian voluntarily participates in this study and signs a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known allergy to dexmedetomidine, lidocaine, or any component of their formulations; 2. Severe heart, lung, liver, or kidney dysfunction; 3. Severe neurological disorders (like uncontrolled epilepsy or intellectual disability) or mental illness that prevents cooperation with assessment; 4. Recent (within 2 weeks) severe respiratory infection; 5. Expected difficult airway (modified Mallampati class IV, limited mouth opening, etc.); 6. Patients expected to need ICU care after surgery; 7. Use of drugs affecting sedation or pain assessment (like sedatives or analgesics) within 24 hours before surgery; 8. Already participating in another study.

Design outcomes

Primary

MeasureTime frame
Incidence of total perioperative respiratory adverse events;

Secondary

MeasureTime frame
Hemodynamic parameters;Postoperative length of stay;Incidence of individual perioperative respiratory adverse events;Early postoperative pain scores;The incidence of adverse events, including bradycardia, hypotension, and postoperative nausea and vomiting;Incidence of emergence agitation;

Countries

China

Contacts

Public ContactChen Lijian

The First Affiliated Hospital of Anhui Medical University

chenlijian77@126.com+86 13966699467

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026