Otitis media
Conditions
Interventions
Remimazolam Combined with Alfentanil Group (Phase I):Children fast for 8 hours and abstain from fluids for 2 hours prior to surgery
upon arrival in the operating room, an intravenous line is established, standard monitoring (ECG, NIBP, SpO2, RR) is initiated, and supplemental oxygen is administered via face mask at 4 L/min. After
they are returned to the ward only after achieving a Steward score >=4 and absence of adverse reactions. The anesthesiologist is aware of the dosing regimen, while data collectors and outcome assessor
Remimazolam Combined with Alfentanil Group (Phase II):In phase two, the alfentanil dose is fixed at the ED95 value determined in phase one, and remimazolam is titrated using the Dixon up-and-down meth
success or failure of anesthesia is assessed based on surgical conditions to determine dose escalation or de-escalation for subsequent patients, continuing until 1
Sponsors
Affiliated Shunde Hospital of Jinan University
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 3 and 12 years; 2. American Society of Anesthesiologists (ASA) classification of grade I or II; 3. Body Mass Index (BMI) within the normal percentile range for children of the same age and gender (typically defined as the 5th to 95th percentile); 4. Scheduled for elective tympanotomy (or tympanostomy tube insertion) under general intravenous anesthesia; 5. The legal guardian of the child fully understands the study content, risks and benefits, and voluntarily signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Anticipated or previous difficulty with mask ventilation or endotracheal intubation; 2. Presence of related systemic diseases: severe respiratory diseases (such as uncontrolled asthma, active respiratory tract infections, bronchopulmonary dysplasia, sleep apnea syndrome), severe cardiovascular diseases (such as congenital heart disease with significant hemodynamic changes, severe arrhythmias, heart failure), neurological diseases or developmental delays (such as epilepsy, increased intracranial pressure, severe cerebral palsy), which may interfere with the assessment of anesthesia depth and recovery quality; 3. Severe liver and kidney dysfunction (Child-Pugh C grade or significant decrease in eGFR), affecting drug metabolism; 4. Known or suspected neuromuscular diseases; 5. Allergy history to benzodiazepines (such as midazolam), opioids (such as the fentanyl family) or their formulation components. Or long-term use of benzodiazepines, opioid analgesics or sedative-hypnotics, with drug tolerance; 6. Participation in other drug clinical trials within the recent 4 weeks; 7. Legal guardians have language or communication barriers, unable to cooperate in completing informed consent and postoperative follow-up; 8. Myringotomy time exceeds 30 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dose sequence for the success or failure of remimazolam or alfentanil obtained by the sequential method; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery Quality (Emergence time, Orientation time, PAED score, FLACC score);Hemodynamic Parameters (BP, HR, SpO2, RR);Adverse reactions (respiratory depression, hypotension, nausea and vomiting, bradycardia, allergic reactions, etc.); | — |
Countries
China
Contacts
Public ContactZhang Zhongqi
Affiliated Shunde Hospital of Jinan University
Outcome results
None listed