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Effect of preoperative intranasal dexmedetomidine on postoperative nausea and vomiting in anxious women undergoing laparoscopic gynecological surgery and analysis of its mediating effect: a prospective, randomized, double-blind, controlled trial

Effect of preoperative intranasal dexmedetomidine on postoperative nausea and vomiting in anxious women undergoing laparoscopic gynecological surgery and analysis of its mediating effect: a prospective, randomized, double-blind, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123489
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Benign Gynecological Diseases

Interventions

Sponsors

The Fifth People's Hospital of Huai'an, Affiliated to Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 to 65 years. 2. Scheduled for elective laparoscopic gynecological surgery (e.g., ovarian cystectomy, myomectomy). 3. American Society of Anesthesiologists (ASA) physical status I–III. 4. Preoperative APAIS anxiety subscale score = 12 (to ensure inclusion of anxious patients). 5. Voluntarily signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Body mass index (BMI) > 30 kg/m² or < 18 kg/m². 2.Nasal pathology (e.g., severe rhinitis, deviated nasal septum, history of recent nasal surgery) that may impair nasal mucosal absorption. 3.Severe bradycardia (HR < 50 bpm) or hypotension (SBP < 90 mmHg). 4.Long-term use of psychotropic medications (with discontinuation < 1 week). 5.Known hypersensitivity or allergy to dexmedetomidine or any of its components. 6.Pregnant or lactating women. 7.History of diagnosed psychiatric disorders (e.g., major depression, schizophrenia), cognitive impairment, or inability to cooperate with the completion of scales.

Design outcomes

Primary

MeasureTime frame
The composite incidence of PONV within 24 hours postoperatively;

Secondary

MeasureTime frame
VAS anxiety score;Rescue antiemetic therapy;The detailed clinical phenotype of PONV;Intraoperative opioid consumption;Quality of recovery;Patient-reported experience and satisfaction;

Countries

China

Contacts

Public ContactKun Dai

The Fifth People's Hospital of Huai'an, Affiliated to Yangzhou University

dai_kun_hawy@outlook.com+86 139 5232 4473

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026