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Comparison of anesthetic effect, quality of consciousness recovery and restlessness during cleft lip and palate repair with different doses of oral midazolam

Comparison of anesthetic effect, quality of consciousness recovery and restlessness during cleft lip and palate repair with different doses of oral midazolam:A Randomized, Double -Blind Clinical Trial Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099524
Enrollment
Unknown
Registered
2025-03-25
Start date
2024-03-29
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Ceft lip and palate

Interventions

Midazolam low dose group:Midazolam was taken orally 0.3mg/kg before surgery
Midazolam high dose group:Midazolam was taken orally 0.5mg/kg before surgery
Normal saline group:Oral equivalent dose of saline before surgery

Sponsors

Stomatological Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: 1. Receiving cleft lip and palate surgery; 2. Aged 0-14 years old; Body weight <=40kg; 3. Signed informed consent; 4. Normal liver and kidney function; 5. ASA grade 1 or 2.

Exclusion criteria

Exclusion criteria: 1. Patients and their families refuse to participate; 2. People with severe allergies; 3. Liver and kidney dysfunction; 4. Have a serious systemic disease, such as heart failure; 5. Have uncorrected malignant arrhythmias; 6. Abnormal somatosensory function; 7. There are central or peripheral nervous system lesions.

Design outcomes

Primary

MeasureTime frame
Sedation score after 30 minutes of administration;Mask acceptance score at induction;Postoperative agitation score;Postoperative pain score;Extubation time;Awakening time;Resuscitation room stay time;Pre-sedation vital signs (blood pressure, respiration rate, heart rate, oxygen saturation);Vital signs after sedation (blood pressure, respiration rate, heart rate, oxygen saturation);Vital signs after intubation (blood pressure, respiration rate, heart rate, oxygen saturation);Vital signs after extubation (blood pressure, respiration rate, heart rate, oxygen saturation);Vital signs upon awakening (blood pressure, respiration, heart rate, oxygen saturation);

Secondary

MeasureTime frame
Postoperative respiratory depression;Postoperative nausea and vomiting;Postoperative bed fall;

Countries

China

Contacts

Public ContactXiaoping Zhang

Stomatological Hospital Affiliated to Wenzhou Medical University

673814856@qq.com+86 137 3203 1279

Outcome results

None listed

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