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Preventive effects of S-ketamine and midazolam on emergence agitation in children undergoing outpatient oral surgery

Preventive effects of S-ketamine and midazolam on emergence agitation in children undergoing outpatient oral surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067985
Enrollment
Unknown
Registered
2023-02-02
Start date
2022-03-15
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

emergence agitation

Interventions

group S:esketamine was administered during induction
group M:midazolam was administered during induction
group NS:normal saline was administered during induction

Sponsors

Xuzhou Children’s Hospital, Xuzhou medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children undergoing outpatient oral surgery under elective general anesthesia; 2. Age 1-7 years old; 3. Weight 10-40kg; 4. ASA class I-II.

Exclusion criteria

Exclusion criteria: 1. Allergic to esketamine hydrochloride or midazolam injection; 2. Preoperative liver and kidney dysfunction or heart disease; 3. There were upper respiratory tract infection symptoms within 1 week before operation; 4. Children with neurological diseases; 5. Acute angle closure glaucoma; 6. The operation time is more than 20min.

Design outcomes

Primary

MeasureTime frame
Incidence of agitation within 30 minutes after operation;

Secondary

MeasureTime frame
Behavioral pain score of children;Awakening time;PACU dwell time;Postoperative adverse reactions;

Countries

CHINA

Contacts

Public ContactYao Junli

Xuzhou Children’s Hospital, Xuzhou medical university

1404568689@qq.com+86 152 9877 1399

Outcome results

None listed

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