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Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Sevoflurane anesthesia is also a known cause of postoperative delirium. Therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.
children aged 3-6 years old were randomly and equally allocated into two groups: Group R remimazolam, Group S with sevoflurane, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group R | Experimental | Induction of anesthesia:Anesthesia will induced with remimazolam at 0.3-0.5 mg/kg; Maintenance of anaesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h). |
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| Group S | Placebo Comparator | Induction of anesthesia:Anesthesia will induced with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min; Maintenance of anaesthesia:Anesthesia depth was maintained at 1-1.5 MAC by sevoflurane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Anesthesia induction:intravenous Fentanyl 2-3 μg/kg, remimazolam 0.3-0.5 mg/kg and Rocuronium 0.6mg/kg; Maintenance of anesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h), and remifentanil will administer at an initial infusion rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of emergence delirium | The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.The degree of emergence delirium increased directly with the total score. Pediatric anesthesia emergence delirium scale ≥10 at any time indicates presence of emergence delirium. | Within up to 30 minutes after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric anesthesia emergence delirium | The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. | Within up to 30 minutes after operation |
| The Face, Legs, Activity, Cry, Consolability Scale (FLACC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huacheng Liu, Ph.D. | Contact | 13957770577 | +86 | huachengliu@163.com |
| Yuhang Cai, M.D. | Contact | 18815091585 | +86 | 838097626@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huacheng Liu, Ph.D. | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38983921 | Derived | Ma HY, Cai YH, Zhong JW, Chen J, Wang Z, Lin CY, Wang QQ, Liu HC. The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial. Front Pharmacol. 2024 Jun 25;15:1373006. doi: 10.3389/fphar.2024.1373006. eCollection 2024. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D000771 | Anesthesia, Intravenous |
| D000077149 | Sevoflurane |
| D000769 | Anesthesia, Inhalation |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
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| Sevoflurane | Drug | Anesthesia induction: Anesthesia will induce with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min, and then intravenous fentanyl (2-3 μg/kg) and rocuronium (0.6 mg/kg); Maintenance of anaesthesia: Anesthesia depth will maintain at 1-1.5 minimum alveolar concentration (MAC), and remifentanil was infuse at an initial rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min). |
|
|
The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10. The degree of pain increased directly with the total score. |
| Within up to 30 minutes after operation |
| Extubation time | The time from discontinuation of anesthesia drug to extubation. | Within up to 30 minutes after operation |
| Recovery times | The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete≥9 | Within up to 30 minutes after operation |
| PHBQ-AS | Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) is a parental report measure used to assess negative behavior change after hospitalization, consisting of 11 items on 1-5 score. The PHBQ-AS score will be calculated for each respondent as the mean score of all individual items answered on the questionnaire. A score above 3 will indicate the presence of negative behavioral change, a score equal to 3 will indicate no behavioral change, and a score below 3 will indicate an improvement in behavior. | 3 days after operation |
| Number of children with adverse effects | Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions | Up to 24 hours including intraoperative, and postoperative periods |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D000768 | Anesthesia, General |