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Study on the Impact of Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Radical Mastectomy

Study on the Impact of Remimazolam on Postoperative Nausea and Vomiting in Patients Undergoing Radical Mastectomy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096743
Enrollment
Unknown
Registered
2025-02-05
Start date
2025-02-08
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Breast Cancer

Interventions

Group A:Anesthetic Induction: 0.2-0.3 mg/kg Remifentanil, 0.4-0.5 µg/kg Sufentanil, and 0.15 mg/kg Cisatracurium administered intravenously
endotracheal intubation after achieving an appropriate depth of anesthesia
maintaining BIS values (45-55), PETCO2 (partial pressure of carbon dioxide in end-tidal breaths) between 35-45 mmHg, and 100% oxygen concentration during surgery. Anesthetic Maintenance: Inhalation o
Group B:Anesthetic Induction: 0.2-0.3 mg/kg Remifentanil, 0.4-0.5 µg/kg Sufentanil, and 0.15 mg/kg Cisatracurium administered intravenously
maintaining BIS values (45-55), end-tidal carbon dioxide partial pressure (PETCO2) between 35-45 mmHg, and 100% oxygen concentration during surgery. Anesthetic Maintenance: Inhaled Sevoflurane mainta
intermittent intravenous administration of Cisatracurium during surgery.
Control Group:Anesthetic Induction: 0.2-0.3 mg/kg Remifentanil, 0.4-0.5 µg/kg Sufentanil, and 0.15 mg/kg Cisatracurium administered intravenously
maintaining BIS values (45-55), PETCO2 (partial pressure of end-tidal carbon dioxide) between 35-45 mmHg, and 100% oxygen concentration during surgery. Anesthetic Maintenance: Inhalation of Sevoflura

Sponsors

Zaozhuang Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age is greater than or equal to 18 years old 2. Pathological examination confirmed breast cancer 3. American Society of Anesthesiologists (ASA) classification grades 1-3 4. Patients and their families have no communication and cognitive barriers, informed consent to this study

Exclusion criteria

Exclusion criteria: 1. Patients with gastrointestinal diseases, severe cardiovascular and respiratory system diseases, liver or kidney diseases 2. Individuals with a history of motion sickness or fainting at the sight of needles 3. Those who refuse to cooperate 4. Patients experiencing nausea or vomiting before surgery 5. Individuals allergic to the medications used in this study

Design outcomes

Primary

MeasureTime frame
(1)PONV:(T1)PACU(T2)0-8h(T3)8-24h(T4). (2)3PONV ,( 0 ~ 3 ) ( 4 ~ 6 ) ( 7 ~ 10) PONV .;Statistics on the grading of PONV in three groups of patients;

Secondary

MeasureTime frame
Evaluate the maximum agitation score during the patient's awakening period using the Ricker Sedation-Agitation Scale, and record the incidence of agitation during the patient's awakening period.;Postoperative sedation effects were evaluated using Ramsay scores at 2, 6, 12, and 24 hours after surgery.;Anesthesia recovery time (recovery of spontaneous breathing, eye opening, recovery of orientation, and tracheal tube removal time);

Countries

China

Contacts

Public ContactZhao Shu

Zaozhuang Municipal Hospital

qddxyjszs@163.com+86 185 6326 1601

Outcome results

None listed

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