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Effects of Dexmedetomidine Combined with Lidocaine Topical Administration on Cough Reflex During Extubation in Children Undergoing Elective Surgery: A Prospective, Randomized Controlled Study

Effects of Dexmedetomidine Combined with Lidocaine Topical Administration on Cough Reflex During Extubation in Children Undergoing Elective Surgery: A Prospective, Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112840
Enrollment
Unknown
Registered
2025-11-20
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Postanesthetic Complications

Interventions

Group D: Dexmedetomidine Combined with Lidocaine (DexLido):Participants in Group D received a combined solution of 1 mL of 2% lidocaine (20 mg) and 1 mL of dexmedetomidine. The dose of dexmedetomidine
Group L: Lidocaine (Lido):Participants in Group L received 2 mL of 2% lidocaine (40 mg). Under video laryngoscopy guidance, the solution was administered via a calibrated spray catheter positioned 1 c
Group C: Normal Saline (Control):Participants in Group C (Control) received 2 mL of normal saline. Under video laryngoscopy guidance, the solution was administered via a calibrated spray catheter posi

Sponsors

The First People's Hospital of Neijiang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Age: 3 to 12 years old (inclusive); 2.ASA Status: American Society of Anesthesiologists (ASA) Physical Status Class I or II; 3.Informed Consent: The child's parent or legal guardian has agreed to the trial procedure and provided written informed consent; 4.Child Assent: Children aged >=7 years old must voluntarily provide their own written assent.

Exclusion criteria

Exclusion criteria: 1.Scheduled surgical duration exceeding 80 minutes; 2.Known hypersensitivity to amide-type local anesthetics or dexmedetomidine; 3.Anticipated difficult airway requiring management with a laryngeal mask airway (LMA) or awake fiberoptic intubation; 4.History of congenital or idiopathic methemoglobinemia, or current use of any medications associated with methemoglobinemia; 5.Pre-existing chronic pharyngitis, or a history of tonsillectomy and/or adenoidectomy; 6.Presence of asthma, recent respiratory tract infection, chronic cough, or requirement for a repeat surgical procedure; 7.Significant cardiovascular disease.

Design outcomes

Primary

MeasureTime frame
The incidence of cough at extubation;

Secondary

MeasureTime frame
The severity of the cough at extubation;The incidence of laryngospasm;The incidence of postoperative sore throat;The incidence of postoperative hoarseness;Pediatric Anesthesia Emergence Delirium (PAED) scale score;Length of stay in the PACU;The incidence of cough at 24 hours postoperatively;Parental satisfaction score at 24 hours postoperatively;

Countries

China

Contacts

Public ContactYihua Wang

The First People's Hospital of Neijiang

646429538@qq.com+86 832 215 5645

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026