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Canceled by the investigator. The effect of small dose of esmketamine on the psycho behavioral factors of children in perioperative period

The effect of small dose of esmketamine on the psycho behavioral factors of children in perioperative period

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030982
Enrollment
Unknown
Registered
2020-03-20
Start date
2020-04-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Postoperative restlessness and behavioral disorders in children

Interventions

Experimental group:D-ketamine 0.5mg / kg, dissolved in 5ml colorless transparent solution using 0.9% physiological saline
control:Same dose of placebo, dissolved in 5ml colorless transparent solution with 0.9% physiological saline

Sponsors

Department of Anesthesiology, Shengjing Hospital affliated to China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing otorhinolaryngology in Shengjing Hospital; 2. Children aged 2-12 years; 3. Patients with general education and basic intelligence test; 4. Before the child's surgery, sign the informed consent form and cooperate to collect the demographic data and medical data of the puerpera.

Exclusion criteria

Exclusion criteria: 1. Patients who are known to be allergic to ketamine, dexketamine or any of the ingredients or excipients of the preparation; 2. Patients who are at risk from elevated blood pressure; 3. With specific contraindications which are aneurysmal vascular disease or arteriovenous malformations and cerebral hemorrhage; 4. Patients with preoperative behavioral disorders and mental illness, patients who have been using psychotropic substances, and children with a history of multiple surgeries.

Design outcomes

Primary

MeasureTime frame
Evaluation of degree of induced cooperation after admission;Postoperative behavior disorder;

Secondary

MeasureTime frame
Preoperative anxiety assessment;Preoperative sedation assessment;Postoperative restlessness assessment;postoperative analgesia;postoperative Sedation;postoperative recognition dysfunction;postoperative satisfaction;

Countries

China

Contacts

Public ContactPing Zhao

Department of Anesthesiology, Shengjing Hospital affliated to China Medical University

zhaop@sj-hospital.org+86 18940258971

Outcome results

None listed

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