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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04621305
Other study ID # SAHoWMU-CR2020-03-113
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 21, 2020
Est. completion date November 2021

Study information

Verified date January 2021
Source Second Affiliated Hospital of Wenzhou Medical University
Contact Huacheng Liu
Phone 18957755138
Email huachengliu@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
normal 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
Drug:
Bolus 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.
Continuous 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.

Locations

Country Name City State
China The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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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