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
- Conditions
- Emergence delirium
- Registration Number
- ChiCTR2400089008
- Lead Sponsor
- The Second Hospital of Hebei Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Child queue: <br>1. Age 3-6 years old; <br>2. ASA grades I-II; <br>3. No dysfunction of neuromuscular conduction and nasopharyngeal diseases; <br>4. Accept tonsillectomy and/or adenoidectomy surgery.<br><br>Gynecological queue: <br>1. Age range of 18 to 70 years old; <br>2. Patients planning to undergo laparoscopic total hysterectomy surgery; <br>3. ASA grades I-II; <br>4. BMI: 18.5~24kg/m^2.
Children's queue:<br>1. Individuals allergic to benzodiazepines and dexmedetomidine drugs; <br>2. Delayed development; <br>3. Suffering from congenital diseases such as megacolon, congenital heart disease, etc;<br>4. Severe heart, lung, liver, and kidney dysfunction; <br>5. Children with neurological disorders; <br>6. Psychological disorders in children with psychological disorders (including behavioral disorders, emotional disorders, hyperactivity syndrome, autism, and developmental delays, etc.); <br>7. Children with severe anemia (Hct<30%); <br>8. Diagnosed children with a history of asthma and epilepsy; <br>9. History of upper respiratory tract infection in the past 2 weeks; <br>10. BMI>=30; <br>11. Children who have already started primary school; <br>12. The patient is currently participating in other studies; <br>13. Parents refuse to participate.<br><br>Gynecological queue: <br>1. Individuals allergic to benzodiazepines and dexmedetomidine drugs; <br>2. Patients with severe underlying diseases such as heart, lung, liver, and kidney; <br>3. Long term use of analgesics or sedatives before surgery; <br>4. Patients with bradycardia and atrioventricular block; <br>5. Patients with severe nasal diseases that are not conducive to drug absorption;<br>6. Patients with angle closure glaucoma; <br>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; <br>8. Participating in other trials; <br>9. The researchers believe that it is not appropriate to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation success rate;Incidence of emergence delirium;
- Secondary Outcome Measures
Name Time Method Incidence of emergence agitation;Incidence of emergence pain;Perioperative respiratory adverse event;Induction Compliance;Post Hospitalization Behavior;Qor-15;