Emergence Delirium Clinical Trial
Official title:
Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia: a Double-blinded Randomized Clinical Trial
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The use of sevoflurane has been identified as one of the most important risk factors. In the investigators' study,the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ED.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | November 2021 |
Est. primary completion date | November 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 6 Years |
Eligibility | Inclusion Criteria: 1. -with American Society of Anesthesiologists (ASA) physical status I or II; 2. -aged 1-6 years; 3. -children with weight for age within the normal range; 4. -were scheduled laparoscopic surgery by sevoflurane anesthesia. Exclusion Criteria: 1. -children who had Abnormal liver and kidney function,Cardiovascular or endocrine dysfunction; 2. -allergy or hypersensitive reaction to remimazolam; 3. -with any organ dysfunction; 4. -recently respiratory infection, mental disorder; 5. -other reasons that researchers hold it is not appropriate to participate in this trial. |
Country | Name | City | State |
---|---|---|---|
China | The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital of Wenzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | End tidal sevoflurane concentration | End tidal sevoflurane concentration at BIS 40-60 | During the preoperative period | |
Secondary | 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 | |
Secondary | FLACC scale | 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 | |
Secondary | Ramsay Sedation Scale score | - The patient is anxious and agitated, restless, or both;
- The patient is cooperative, oriented, and tranquil; - The patient responds to commands only; - The patient is asleep and shows a brisk response to a light glabellar tap or loud auditory stimulus; - The patient is asleep and shows a slow response to a light glabellar tap or loud auditory stimulus; - The patient is asleep and shows no response to a light glabellar tap or loud auditory stimulus. The degree of sedation increased directly with the total score. |
Within up to 30 minutes after operation | |
Secondary | Recovery times | The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete=9 | Up to 30 minutes after operation | |
Secondary | Number of children with adverse effects | 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 |
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