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

Phase 4

• Conditions: Emergence Delirium
• Interventions: Other: normal saline; Drug: Continuous Infusion Remimazolam; Drug: Bolus Remimazolam

• Registration Number: NCT04621305
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Study Start: 2020-11-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group P (Placebo group)	normal saline	Patients were assigned to group P (Placebo group) using a computer-generated random number table
group C (continuous infusion group)	Continuous Infusion Remimazolam	Patients were assigned to group C (continuous infusion group) using a computer-generated random number table
group B (Bolus group)	Bolus Remimazolam	Patients were assigned to group B (Bolus group) using a computer-generated random number table

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
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
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.

Trial Locations

Locations (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China