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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-21

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group P (Placebo group)

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

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

group B (Bolus group)

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

Group Type EXPERIMENTAL

Bolus Remimazolam

Intervention Type DRUG

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.

group C (continuous infusion group)

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

Group Type EXPERIMENTAL

Continuous Infusion Remimazolam

Intervention Type DRUG

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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Placebo group Bolus group Continuous infusion group

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes