Skip to content

Comparison of Remimazolam with Propofol on Incidence of PONV in Patients Undergoing Gynecological Laparoscopic Surgery: a Prospective, Randomized, Clinical Trial

Comparison of Remimazolam with Propofol on Incidence of PONV in Patients Undergoing Gynecological Laparoscopic Surgery: a Prospective, Randomized, Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076452
Enrollment
Unknown
Registered
2023-10-09
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-09-30

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

Group R:Induction with remazolam 0.3mg/kg (1min), sufentanil 0.3ug/kg (30s), cisatracurium 0.2mg/kg (15s)
maintenance with remazolam (0.1-0.3mg/kg/h), sevoflurance (1.5%), remifentanil (0.075~0.2µg/kg/min), and BIS 40~60.
Group P:Induction with propofol 2mg/kg (1min), sufentanil 0.3ug/kg (30s), cisatracurium 0.2mg/kg (15s)
maintenance with propofol (2-3.5ug/ml, TCI), sevoflurance (1.5%), remifentanil (0.075~0.2µg/kg/min), and BIS 40~60.

Sponsors

The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects recieving elective gynecologic laparoscopy under general anesthesia; 2. ASA grade I~III; 3. Aged 18 to 65 years; 4. Sugery time >= 30 minutes; 5. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to Remimazolam or Propofol; 2. Schizophrenia or depression; 3. Emergency surgery; 4. Massive bleeding during the operation, and the shock time more than 30 minutes.

Design outcomes

Primary

MeasureTime frame
The incidence of PONV within 24h afer sugery;

Secondary

MeasureTime frame
The incidence of injection pain ;The incidence of hypotension (systolic BP < 90 mmHg or 25% decrease from baseline) within 10 minutes during inductiontion ;The incidence of remedial antiemesis;Nausea rating;patient satisfaction;

Countries

China

Contacts

Public ContactMo Liqiu

The First Affiliated Hospital, Sun Yat-sen University

moliqiu@mail.sysu.edu.cn+86 139 2418 1269

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 18, 2026