MedDataX Logo

Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation

NCT ID: NCT05925283

Last Updated: 2023-06-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

midazolam

Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type DRUG

oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.

esketamine

Patients were assigned to receive intranasal esketamine 1mg/kg approximately 30-40 minutes before surgery using a computer-generated random number table.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

intranasal esketamine 1mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.

midazolam and esketamine

Patients were assigned to receive intranasal esketamine 0.6mg/kg and oral midazolam 0.3mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.

Group Type EXPERIMENTAL

midazolam and esketamine

Intervention Type DRUG

oral midazolam 0.3mg/kg and intranasal esketamine 0.6mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Midazolam

oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.

Intervention Type DRUG

Esketamine

intranasal esketamine 1mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.

Intervention Type DRUG

midazolam and esketamine

oral midazolam 0.3mg/kg and intranasal esketamine 0.6mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oral midazolam Intranasal esketamine combination with intranasal esketamine and oral midazolam

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 2-6 years；
3. children with weight for age within the normal range
4. were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.

Exclusion Criteria

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either esketamine or midazolam;
3. with any nasal pathology,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

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Huacheng Liu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Xulin Zhang

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Huacheng Liu

Role: CONTACT

Phone: 18957755138

Email: [email protected]

Xulin Zhang

Role: CONTACT

Phone: 18583748800

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAHoWMU-CR2023-03-105

Identifier Type: -

Identifier Source: org_study_id