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Effect of oral midazolam on preoperative and recovery characteristics of children with ocular surgery under intravenous-inhalational anesthesia

Effect of oral midazolam on preoperative and recovery characteristics of children with ocular surgery under intravenous-inhalational anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091895
Enrollment
Unknown
Registered
2024-11-05
Start date
2023-09-03
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

None

Interventions

Group A:Take 0.2 mg/kg oral midazolam solution 30min before surgery
Group B:Take 0.2 mg/kg midazolam injection and 5% glucose mixture 30min before surgery
Group C:Take 5% glucose solution 30min before surgery
Group D:Take 0.1 mg/kg oral midazolam solution 30min before surgery
Group E:Take 0.2 mg/kg oral midazolam solution 30min before surgery
Group F:Take 0.3mg/kg oral midazolam solution 30min before surgery
Group G:Take 0.2mg/kg oral midazolam solution 10min before surgery
Group H:Take 0.2mg/kg oral midazolam solution 20min before surgery
Group I:Take 0.2mg/kg oral midazolam solution 30min before surgery

Sponsors

Hebei Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Uniform inclusion criteria were used for all groups: (1) ASA I-II children aged 2-12 years old, regardless of gender, who plan to choose small or medium sized surgery under intravenous aspiration combined anesthesia; (2) The BMI of the child does not exceed 30% of the maximum normal value for the age; (3) The expected operation time is less than 60 minutes; (4) The type of surgery was pediatric strabismus correction

Exclusion criteria

Exclusion criteria: Uniform exclusion criteria were used for all groups: (1) Complicated with liver, kidney, central nervous system or metabolic diseases; (2) Children who are allergic to the drugs used in the study; (3) Children with a history of anesthesia and surgery; (4) Family members do not agree to enter the study.

Design outcomes

Primary

MeasureTime frame
modified Yale Preoperative Anxiety Scale,m-YPAS;Parental Separation Anxiety Scale,PSAS;Mask Acceptance Scale, MAS;

Secondary

MeasureTime frame
pediatric anesthesia emergence delirium scale,PAEDS;FLACC(Face,Legs,Activity,Cry,Consolability);Improved Aldrete score;Mask insertion time (from induction to mask insertion);Heart rate changes when the laryngeal mask is inserted;

Countries

China

Contacts

Public ContactHao Sun

Hebei Eye Hospital

18330105761@163.com+86 155 3094 5530

Outcome results

None listed

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