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Effect of amisulpride combined with intranasal dexmedetomidine on postoperative nausea and vomiting and sleep quality in patients undergoing gynecological laparoscopy

Effect of amisulpride combined with intranasal dexmedetomidine on postoperative nausea and vomiting and sleep quality in patients undergoing gynecological laparoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127722
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Postoperative nausea and vomiting (PONV)

Interventions

Control group (C group):placebo control
Amisulpride group (D group):Intravenous amisulpride
Amisulpride combined with intranasal dexmedetomidine group (AD group):Amisulpride combined with intranasal dexmedetomidine

Sponsors

The First People’s Hospital of Hefei
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged 18-64; 2. ASA (American Society of Anesthesiologists) physical status I-II; 3. Patients scheduled for elective gynecological laparoscopic surgery under general anesthesia with intubation; 4. Normal or mildly abnormal liver and kidney function before surgery; 5. Informed consent signed by the patient herself or her legal representative.

Exclusion criteria

Exclusion criteria: 1. Preoperative baseline heart rate <50 bpm (average of 3 consecutive measurements at rest); 2. Presence of nausea or vomiting before surgery; 3. Allergy or contraindication to study-related drugs such as amisulpride, dexmedetomidine, sevoflurane, propofol, etc.; 4. Significant abnormalities in heart, lung, liver, or kidney function; 5. Previously diagnosed chronic digestive system disease; 6. History of PONV or motion sickness; 7. Presence of hearing impairment or intellectual developmental disorder (unable to cooperate with scale assessment and follow-up).

Design outcomes

Primary

MeasureTime frame
Complete response (CR) rate for postoperative nausea and vomiting within 24 hours after surgery;—

Secondary

MeasureTime frame
LSEQ scores on postoperative days 1–3;Incidence of adverse events within 7 days after surgery;Rescue antiemetic use within 24 hours after surgery;The frequency of nausea/vomiting within 24 hours after surgery.;Incidence of significant nausea within 24 hours after surgery;Insomnia Severity Index (ISI) score at discharge;Pittsburgh Sleep Quality Index (PSQI) score at discharge;—

Countries

China

Contacts

Public ContactJingYi Niu

The First People’s Hospital of Hefei

niujingyi225182@163.com+86 551 6218 3386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026