Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia

NCT06214117 | Unknown Phase 4

• 1 other identifier: SAHoWMU-CR2024-03-103
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Sevoflurane anesthesia is also a known cause of postoperative delirium. Therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.

Conditions

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)

• Pediatric anesthesia emergence delirium

  Within up to 30 minutes after operation

• The Face, Legs, Activity, Cry, Consolability Scale (FLACC)

  Within up to 30 minutes after operation

• Extubation time

  Within up to 30 minutes after operation

• Recovery times

  Within up to 30 minutes after operation

• PHBQ-AS

  3 days after operation

Study Arms (2)

Group R

EXPERIMENTAL

Induction of anesthesia:Anesthesia will induced with remimazolam at 0.3-0.5 mg/kg; Maintenance of anaesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h).

Drug: Remimazolam

Group S

PLACEBO COMPARATOR

Induction of anesthesia:Anesthesia will induced with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min; Maintenance of anaesthesia:Anesthesia depth was maintained at 1-1.5 MAC by sevoflurane.

Drug: Sevoflurane

Interventions

Remimazolam DRUG

Anesthesia induction:intravenous Fentanyl 2-3 μg/kg, remimazolam 0.3-0.5 mg/kg and Rocuronium 0.6mg/kg; Maintenance of anesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h), and remifentanil will administer at an initial infusion rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min).

Also known as: intravenous anesthesia

Group R

Sevoflurane DRUG

Anesthesia induction: Anesthesia will induce with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min, and then intravenous fentanyl (2-3 μg/kg) and rocuronium (0.6 mg/kg); Maintenance of anaesthesia: Anesthesia depth will maintain at 1-1.5 minimum alveolar concentration (MAC), and remifentanil was infuse at an initial rate of 0.25 μg/kg/min (0.1-0.5 μg/kg/min).

Also known as: inhalation anesthesia

Group S

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-6 years;
• American Society of Anaesthesiologist (ASA) I or II;
• Booked for Tonsillectomy and Adenoidectomy;
• BMI for age between the 25th and 85th percentiles according to the 2000 Centers for Disease Control and Prevention (CDC) growth charts.

You may not qualify if:

• Children (ASA III- IV) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction;
• Allergy or hypersensitive reaction to remimazolam;
• mental disorder
• Recently respiratory infection;
• Other reasons that researchers hold it is not appropriate to participate in this trial: under specialized care or lived in social welfare institutions, or any other factors that could affect their ability to participate in the study.

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

Location

Related Publications (1)

• Ma HY, Cai YH, Zhong JW, Chen J, Wang Z, Lin CY, Wang QQ, Liu HC. The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial. Front Pharmacol. 2024 Jun 25;15:1373006. doi: 10.3389/fphar.2024.1373006. eCollection 2024.

  PMID: 38983921 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolam; Anesthesia, Intravenous; Sevoflurane; Anesthesia, Inhalation

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)

Anesthesia; Anesthesia and Analgesia; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Anesthesia, General

Study Officials

• Huacheng Liu, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu, Ph.D.

CONTACT

13957770577; huachengliu@163.com

Yuhang Cai, M.D.

CONTACT

18815091585; 838097626@qq.com

Study Design

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

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 19, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

CN (1)