Emergence Delirium
Conditions
Keywords
remimazolam, emergence delirium
Brief summary
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.
Detailed description
One hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. Anesthesia is induced with propofol，fentanyl and rocuronium. In group P (Placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. In group B (Bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. In group C (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. Maintain BIS values in the range of 40-60. Recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
Interventions
OTHERnormal saline
Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered
DRUGBolus Remimazolam
Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered.
DRUGContinuous Infusion Remimazolam
Anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered.
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of emergence delirium | Within up to 30 minutes after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric anesthesia emergence delirium | Within up to 30 minutes after operation | 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. |
| FLACC scale | Within up to 30 minutes after operation | 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. |
| End tidal sevoflurane concentration | During the preoperative period | End tidal sevoflurane concentration at BIS 40-60 |
| Recovery times | Up to 30 minutes after operation | The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldrete≥9 |
| Number of children with adverse effects | Up to 24 hours including intraoperative, and postoperative periods | 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 |
| Ramsay Sedation Scale score | Within up to 30 minutes after operation | 1. \- The patient is anxious and agitated, restless, or both; 2. \- The patient is cooperative, oriented, and tranquil; 3. \- The patient responds to commands only; 4. \- The patient is asleep and shows a brisk response to a light glabellar tap or loud auditory stimulus; 5. \- The patient is asleep and shows a slow response to a light glabellar tap or loud auditory stimulus; 6. \- 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. |
Countries
China
Contacts
Primary ContactHuacheng Liu
Backup ContactYuhang Cai
Outcome results
None listed