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

NCT04621305 | Unknown Phase 4

• 1 other identifier: SAHoWMU-CR2020-03-113
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Keywords

remimazolam; emergence delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• End tidal sevoflurane concentration

  During the preoperative period

• Pediatric anesthesia emergence delirium

  Within up to 30 minutes after operation

• FLACC scale

  Within up to 30 minutes after operation

• Ramsay Sedation Scale score

  Within up to 30 minutes after operation

• Recovery times

  Up to 30 minutes after operation

Study Arms (3)

group P (Placebo group)

PLACEBO COMPARATOR

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

Other: normal saline

group B (Bolus group)

EXPERIMENTAL

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

Drug: Bolus Remimazolam

group C (continuous infusion group)

EXPERIMENTAL

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

Drug: Continuous Infusion Remimazolam

Interventions

normal saline 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

Also known as: Placebo group

group P (Placebo group)

Bolus Remimazolam 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.

Also known as: Bolus group

group B (Bolus group)

Continuous Infusion Remimazolam 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.

Also known as: Continuous infusion group

group C (continuous infusion group)

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• with American Society of Anesthesiologists (ASA) physical status I or II；
• aged 1-6 years；
• children with weight for age within the normal range；
• were scheduled laparoscopic surgery by sevoflurane anesthesia.

You may not qualify if:

• children who had Abnormal liver and kidney function,Cardiovascular or endocrine dysfunction;
• allergy or hypersensitive reaction to remimazolam;
• with any organ dysfunction;
• recently respiratory infection, mental disorder;
• other reasons that researchers hold it is not appropriate to participate in this trial.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Huacheng Liu

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Yuhang Cai

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu

CONTACT

18957755138; huachengliu@163.com

Yuhang Cai

CONTACT

18815091585; 838097626@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: November 21, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)