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Clinical and Mechanistic Study on the Effect of Dexmedetomidine Nasal Spray on Postoperative Anxiety and Depression in Patients with Pregnancy Loss

Clinical and Mechanistic Study on the Effect of Dexmedetomidine Nasal Spray on Postoperative Anxiety and Depression in Patients with Pregnancy Loss

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125571
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Perinatal anxiety and depression

Interventions

Dexmedetomidine group:Intranasal dexmedetomidine at a dose of 1µg/kg
Placebo group:Administer the same amount of normal saline intranasally

Sponsors

Nanjing Medical University Affiliated Maternity Hospital (Nanjing Maternal and Child Health Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. women aged 18-50 years old;2. with ASA classification of I or II; 3.who are pregnant and have experienced miscarriage (including missed abortion, spontaneous abortion or empty pregnancy); 4.with a score of >=5 on the Generalized Anxiety Disorder-7 (GAD-7) scale (indicating mild or above levels of anxiety);5.and who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Body weight 30 kg/m^2; 2. Lactating patients; 3. Those with a history of sleep apnea; 4. Those currently using opioid or non-opioid analgesics for pain control; 5. Those currently taking other drugs that can affect sedation and analgesia responses, such as central a-adrenergic drugs (clonidine or dexmedetomidine, etc.), antiepileptic drugs, neuroleptics, antidepressants, antipsychotic drugs, etc.; 6. Those who have used corticosteroids within 3 months; 7. Preoperative electrocardiogram abnormalities (prolonged QTc, frequent ventricular premature beats, etc.) and liver and kidney function impairment; 8. Other postoperative exclusion criteria include: anesthetic adverse events such as allergy, bronchospasm, hemodynamic instability during surgery, as well as surgery-related adverse events such as uterine perforation and intestinal injury.

Design outcomes

Primary

MeasureTime frame
Anxiety score 7 days after the operation, the rate of decline in anxiety score and the rate of anxiety relief;Anxiety score 42 days after the operation, the rate of decline in anxiety score and the rate of anxiety relief;Anxiety score 180 days after the operation, the rate of decline in anxiety score and the rate of anxiety relief;Anxiety score 360 days after the operation, the rate of decline in anxiety score and the rate of anxiety relief;

Secondary

MeasureTime frame
The dosage of propofol used during the operation, the incidence of adverse events such as hypoxemia, hypotension, bradycardia, and postoperative nausea and vomiting;The quality of recovery 24 hours after the operation, postoperative pain score, postoperative sleep quality;Short-term and long-term postoperative (on the 7th day, 42nd day and half a year/year after the operation) depression and grief scores and their remission status;Functional magnetic resonance imaging (MRI) examinations were conducted before and after the operation;

Countries

China

Contacts

Public ContactFeng Shanwu

Nanjing Medical University Affiliated Obstetrics and Gynecology Hospital (Nanjing Maternal and Child Health Hospital)

jiangmingnjfy@163.com+86 139 2142 6351

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026