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Comparison of S-ketamine and midazolam for preoperative sedative and anxiolytic effects in preschool children: study protocol for a randomized controlled trial

Comparison of S-ketamine and midazolam for preoperative sedative and anxiolytic effects in preschool children: study protocol for a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069998
Enrollment
Unknown
Registered
2023-03-30
Start date
2023-03-31
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preoperative anxiety

Interventions

Group S:Esketamine 0.5mg/kg, iv
Group M:Midazolam 0.08mg/kg, iv

Sponsors

Department of anesthesia, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Age between 2 and 6 years; 2. ASA graded at ?-? level; 3. Elective surgery under general anesthesia; 4. An intravenous cannula was inserted preoperatively; 5. the children's guardians or caregivers voluntarily participated in this project and provided informed consent

Exclusion criteria

Exclusion criteria: 1. Children with congenital heart disease (such as tetralogy of Fallot, arterial catheterization, etc.); 2. The child has respiratory system diseases (such as pulmonary infection, bronchospasm, etc.); 3. Children with central nervous system disorders (epilepsy, cerebral palsy, Down syndrome, etc.); 4. Liver and renal dysfunction in children; 5. Known difficult airways; 6. Long-term use of sedative and analgesic drugs before surgery; 7. Allergies to narcotic drugs

Design outcomes

Primary

MeasureTime frame
modified Yale Preoperative Anxiety Scale;

Secondary

MeasureTime frame
parent separation anxiety score;caregivers and anesthesia care providers’ satisfaction;

Countries

PRC

Contacts

Public ContactZuo Yunxia

Department of anesthesia, West China Hospital, Sichuan University

zuoyunxiahxa@qq.com+86 189 8060 1541

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026