Effect of Esketamine combined with midazolam on preoperative sedation in preschool children: a randomized, double-blind, controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066620

Enrollment

Unknown

Registered

2022-12-12

Start date

2022-12-15

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

preoperative sedation

Interventions

Control group:0.5mg/kg midazolam was given orally in sugar water 30 minutes before anesthesia induction

Experimental group:1mg/kg esketamine + 0.75mg/kg midazolam was given to sugar water 30 minutes before anesthesia induction to make the concentration of midazolam in the configuration liquid reach 2mg/

Eligibility

Sex/Gender

All

Age

2 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1.ASA I-II; 2.2-5 years old; 3.The duration of the operation = 1 hour; 4.Laparoscopic repair of inguinal oblique hernia or laparoscopic high ligation of sphingoid process should be performed; 5.Volunteer to participate in this experiment and sign the informed consent statement; 6.Meet weight criteria: age/gender Weight range (including values at both ends) Two-year-old boy/girl 11.2kg~15.7kg/10.7kg~14.9kg Three-year-old boy/girl 13.1kg~18.4kg/12.7kg~17.8kg four-year-old boy/girl 14.9kg~21.0kg/14.4kg~20.5kg Five-year-old boy/girl 16.9kg~24.4kg/16.2kg~23.5kg

Exclusion criteria

Exclusion criteria: 1. Subjects with mental system diseases and cognitive dysfunction; 2. History or possibility of difficult airway, such as obstructive sleep apnea syndrome (OSA); 3. Abnormal function of nervous system, cardiovascular system, endocrine system and liver and kidney; 4. Those who are allergic to esketamine, midazolam, propofol, flumazenil and other pharmaceutical ingredients or components; 5. Subjects who had general anesthesia within 14 days before randomization.

Design outcomes

Primary

Measure	Time frame
Time to achieve satisfactory sedation (Ramsay sedation score= 3);	—

Secondary

Measure	Time frame
Time of onset;Time of PSAS=1;m-YPAS;ICS;Incidence of midazolam paradoxical reactions;MAS;Anaesthetic recovery time;Anterograde amnesia;PAED;The time between the start of oral administration and the first Steward score = 4 points;PHBQ;	—

Countries

China

Contacts

Public ContactLin Han

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

nanlinhannansh@qq.com15868710831

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026