Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia (CEDCRSA)

Second Affiliated Hospital of Wenzhou Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Emergence Delirium

Treatments: Drug: Sevoflurane; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06214117

SAHoWMU-CR2024-03-103

Details and patient eligibility

About

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.

Full description

children aged 3-6 years old were randomly and equally allocated into two groups: Group R remimazolam, Group S with sevoflurane, respectively.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Children (ASA III- IV) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction;
2. Allergy or hypersensitive reaction to remimazolam;
3. mental disorder
4. Recently respiratory infection;
5. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 2 patient groups, including a placebo group

Group R

Experimental group

Description:

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).

Treatment:

Drug: Remimazolam

Group S

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane