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Effect of dexmedetomidine nasal spray on postoperative sleep quality in children

Effect of dexmedetomidine nasal spray on postoperative sleep quality in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102992
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Postoperative sleep disturbance in children

Interventions

Dexmedetomidine nasal spray group (Nasal spray was given at about 21:45 on the evening after operation and at 21:45 on the day after operation (once a day in the evening, one spray on the left and rig
Control group (Dexmedetomidine nasal spray was not given on the night after operation and one night after operation):None

Sponsors

Chengdu Women's and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: a) ASA I ~ II, aged 1-5 years old, diagnosed as hypospadias, to be treated by urethroplasty with longitudinal cutting of urethral plate and rolling tube method. b) The patient had no history of hypertension, diabetes mellitus, heart disease, chronic obstructive pulmonary disease, asthma, epilepsy, brain trauma and brain surgery before surgery, and the patient had no nasal deformity. c) a 2 receptor agonists were not used in the past 1 month.

Exclusion criteria

Exclusion criteria: a) Sinus bradycardia and atrioventricular block. b) History of nasal surgery or nasal diseases, including rhinitis, nasal polyps and sinusitis, and sleep apnea syndrome. c) Postoperative complications such as infection, poor wound healing, urinary fistula, and postoperative dysuria affect sleep. d) Children who received opioid analgesia in addition to the postoperative analgesia pump. e) Sedative hypnotic drugs were used within 3 months. f) Children with depression, anxiety disorder and sleep disorder. g) Children with sleep delay, sleep interruption and early awakening due to treatment, noisy ward and temperature discomfort at night.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI);Visual Analogue Scale (VAS);

Secondary

MeasureTime frame
Insomnia Severity Index (ISI);

Countries

China

Contacts

Public ContactBo Wu

Chengdu Women's and Children's Central Hospital

wb19890201@126.com+86 182 0024 6216

Outcome results

None listed

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