Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04621305
• Other study ID #: SAHoWMU-CR2020-03-113
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

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