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Standardized clinical pathway of preoperative sedation guided by preoperative anxiety in children undergoing tonsillectomy and adenoidectomy——Comparison of the safety of rescue application of Esketamine or Propofol after failed separation of intravenous midazolam

Standardized clinical pathway of preoperative sedation guided by preoperative anxiety in children undergoing tonsillectomy and adenoidectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073222
Enrollment
Unknown
Registered
2023-07-04
Start date
2023-07-05
Completion date
Unknown
Last updated
2023-07-10

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

Conditions

Preoperative anxiety

Interventions

Propofol group:Failed separation when intravenous injection of 0.05mg/kg of midazolam, than Propofol 2 mg/kg was administered intravenously.
Esketamine group:Failed separation when intravenous injection of 0.05mg/kg of midazolam, than Eskekamine 0.05 mg/kg was administered intravenously.

Sponsors

EYE & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

Inclusion criteria: Children aged 2-10 years old; ASA grading I - II; Receiving elective tonsil and/or adenoid surgery under general anesthesia; Parent-child separation failed after intravenous injection of midazolam.

Exclusion criteria

Exclusion criteria: The child is allergic to the experimental medication; Children with neurological and psychiatric disorders; The child is not accompanied by a guardian; Cancellation or postponement of surgery; The guardian refused to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
The incidence of hypoxemia (SpO2<92% for more than 10s) during the period from administration to induction of anesthesia.;

Secondary

MeasureTime frame
Is there any physical activity during the period from administration to anesthesia induction;Is there any coughing during the period from administration to induction of anesthesia;Other adverse events during the period from administration to anesthesia induction;Drug onset time;Does the child have resistance during mask pre oxygenation;Heart rate of the child before administration;Oxygen saturation of the child before administration;The heart rate of the child at the onset of drug action;Lowest oxygen saturation during administration to anesthesia induction;Heart rate at the lowest oxygen saturation;The occurrence time of the lowest oxygen saturation;Duration of oxygen saturation less than 92%;Time from administration to induction of anesthesia;Respiratory recovery time after entering the resuscitation room;Extubation time after entering the resuscitation room;Recovery time;Emergence agitation score;Children's Pain Score (FLACC Score) during 24 hours after surgery;Incidence of nausea and vomiting during 24 hours after surgery;

Countries

China

Contacts

Public ContactJie Jia

EYE & ENT Hospital of Fudan University

jiajie@eentanesthesia.com+86 136 4183 9213

Outcome results

None listed

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