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Single intravenous dexmedetomidine combined with esmketamine undergoing pediatric tonsillectomy and adenoid adenoidectomy: a prospective, randomized, controlled, double-blind, single center clinical trial

Single intravenous dexmedetomidine combined with esmketamine undergoing pediatric tonsillectomy and adenoid adenoidectomy: a prospective, randomized, controlled, double-blind, single center clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037603
Enrollment
Unknown
Registered
2020-08-29
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

emergence agitation in children

Interventions

C:Intravenous injection of normal saline
D:Intravenous injection of 0.5ug/kg dexmedetomidine
K:Intravenous injection of 0.25mg/kg esketamine
DK:Intravenous injection of 0.3ug/kg dexmedetomine + 0.15mg/kg esketamine

Sponsors

the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universtiy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1) Aged 3-7 years ; (2) ASA I-II; (3) Normal liver and kidney function; (4) No previous history of allergy to anesthetics; (5) Signing informed consent.

Exclusion criteria

Exclusion criteria: (1) Known allergy to active ingredients or excipients in anesthetics; (2) glucose-6-phosphate dehydrogenase deficiency; (3) History of arrhythmia, bronchial and cardiovascular diseases, liver dysfunction, etc.; (4) Use of a2 receptor agonists or antagonists; (5) Use of analgesics or sedatives within two days before operation; (6) Mental or nervous system diseases; (7) Use of other experiment drug 3 months before screening period; (8) Patients with history or possibility of difficult airway, such as obstructive sleep apnea syndrome (OSA); (9) Allergic to dexmedetomidine, ketamine, propofol, opioids and other drug ingredients or components; (10) Other conditions judged by the researchers as not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
postoperative agitation in children ;

Secondary

MeasureTime frame
FLACC pain score;Ramsay sedation score;Heart rate and blood pressure;Awaken time;Retention time in PACU;

Countries

China

Contacts

Public ContactHuacheng Liu

he Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universtiy

huachengliu@163.com+86 13957770577

Outcome results

None listed

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