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A prospective, multicenter, randomized controlled clinical trial of dexmedetomidine nasal spray for preoperative sedation and prevent emergence delirium in different populations of patients who undergoing surgery

A prospective, multicenter, randomized controlled clinical trial of dexmedetomidine nasal spray for preoperative sedation and prevent emergence delirium in different populations of patients who undergoing surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089008
Enrollment
Unknown
Registered
2024-08-30
Start date
2024-09-16
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Emergence delirium

Interventions

(Children's queue) dexmedetomidine group:Preoperative administration of dexmedetomidine nasal spray based on body weight
(Children's queue) midazolam group:Preoperative oral administration of midazolam based on body weight
(Gynecological queue) Dexmedetomidine group:Preoperative administration of 100ug of dexmedetomidine nasal spray
(Gynecological queue) midazolam group:Preoperative intravenous administration of midazolam 0.05mg/kg

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 70 Years

Inclusion criteria

Inclusion criteria: Child queue: 1. Age 3-6 years old; 2. ASA grades I-II; 3. No dysfunction of neuromuscular conduction and nasopharyngeal diseases; 4. Accept tonsillectomy and/or adenoidectomy surgery. Gynecological queue: 1. Age range of 18 to 70 years old; 2. Patients planning to undergo laparoscopic total hysterectomy surgery; 3. ASA grades I-II; 4. BMI: 18.5~24kg/m^2.

Exclusion criteria

Exclusion criteria: Children's queue: 1. Individuals allergic to benzodiazepines and dexmedetomidine drugs; 2. Delayed development; 3. Suffering from congenital diseases such as megacolon, congenital heart disease, etc; 4. Severe heart, lung, liver, and kidney dysfunction; 5. Children with neurological disorders; 6. Psychological disorders in children with psychological disorders (including behavioral disorders, emotional disorders, hyperactivity syndrome, autism, and developmental delays, etc.); 7. Children with severe anemia (Hct=30; 11. Children who have already started primary school; 12. The patient is currently participating in other studies; 13. Parents refuse to participate. Gynecological queue: 1. Individuals allergic to benzodiazepines and dexmedetomidine drugs; 2. Patients with severe underlying diseases such as heart, lung, liver, and kidney; 3. Long term use of analgesics or sedatives before surgery; 4. Patients with bradycardia and atrioventricular block; 5. Patients with severe nasal diseases that are not conducive to drug absorption; 6. Patients with angle closure glaucoma; 7. Preoperative MMSE scores are less than 17 for illiterate patients, less than 20 for patients with primary school education, and less than 24 for patients with secondary school or higher education; 8. Participating in other trials; 9. The researchers believe that it is not appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;Incidence of emergence delirium;

Secondary

MeasureTime frame
Incidence of emergence agitation;Incidence of emergence pain;Perioperative respiratory adverse event;Induction Compliance;Post Hospitalization Behavior;Qor-15;

Countries

China

Contacts

Public ContactGao jingui

The Second Hospital of Hebei Medical University

gaojingui@126.com+86 158 0321 0586

Outcome results

None listed

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