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

Second Affiliated Hospital of Wenzhou Medical University

Status and phase: Unknown; Phase 4

Conditions: Emergence Delirium

Treatments: Drug: Continuous Infusion Remimazolam; Other: normal saline; Drug: Bolus Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT04621305

SAHoWMU-CR2020-03-113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

group P (Placebo group)

Placebo Comparator group

Description:

Patients were assigned to group P (Placebo group) using a computer-generated random number table

Treatment:

Other: normal saline

group B (Bolus group)

Experimental group

Description:

Patients were assigned to group B (Bolus group) using a computer-generated random number table

Treatment:

Drug: Bolus Remimazolam

group C (continuous infusion group)

Experimental group

Description:

Patients were assigned to group C (continuous infusion group) using a computer-generated random number table

Treatment:

Drug: Continuous Infusion Remimazolam