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To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy, aiming to enhance surgical safety and improve postoperative outcomes in pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol group | Active Comparator | Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h) |
|
| Remimazolam group | Experimental | Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h) |
|
| Ciprofol group | Experimental | Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of perioperative respiratory adverse events | The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction. | 5days |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia duration | From anesthesia induction to discontinuation of anesthetics | 1 day |
| Emergence time | From anesthetic discontinuation to eye opening on command |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pu Zhou | Contact | 02783663625 | tongjihlunli@163.com | |
| Aihua Du | Contact | 02783663625 | 70663307@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Mujun Chang | Tongji Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h) |
|
|
| Ciprofol | Drug | Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h) |
|
|
| 1 day |
| Extubation time | From anesthetic discontinuation to endotracheal tube removal | 1 day |
| PACU stay duration | From PACU admission to meeting discharge criteria | 1 day |
| The modified Aldrete score | Upon admission to the PACU, the child was assessed using the modified Aldrete score, which ranges from 0 to 10. A higher score indicates a better recovery status. | 1 day |
| doses of drugs | Total sedative/analgesic consumption | 24 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |