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Study on the Sedative and Analgesic Effects of Propofol and Alfentanil in Pain-Free Abortion Surgery

Study on the Sedative and Analgesic Effects of Propofol and Alfentanil in Pain-Free Abortion Surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110395
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Painless abortion

Interventions

AC 0.5 group:Patients in the AC 0.5 group received a mixture of 0.05 mL/kg (drug preparation method: uniformly mix 1 mL of alfentanil (0.5 mg) and 19 mL of propofol (47.5 mg) in a 20 mL syringe). to
AC 0.75 group:Patients in the AC 0.75 group received a mixture of 0.05 mL/kg (drug preparation method: uniformly mix 1.5 mL of alfentanil (0.75 mg) and 18.5 mL of propofol (46.25 mg) in a 20 mL syring
AC1.0 group:Patients in the AC 1.0 group received 0.05 mL/kg of the mixture (drug preparation method: uniformly mix 2 mL of alfentanil (1.0 mg) and 18 mL of propofol (45 mg) in a 20 mL syringe), follo
ACS group:Patients in the ACS group received the mixture (drug preparation method: uniformly mix 1.5 mL of alfentanil at 0.75 mg with 18.5 mL of propofol at 46.25 mg in a 20 mL syringe) at a dose of 0
PCS group:Patients in the PCS group continuously pressed the handle, with medication delivered via an extension tube and three-way stopcock through an infusion pump. The infusion pump was set to an in

Sponsors

The Second Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Clearly understand and voluntarily participate in the study by signing the informed consent form. 2.After confirming intrauterine pregnancy through pregnancy tests and ultrasound examination, voluntarily undergo a painless abortion procedure. 3. Be at least 18 years of age, have a body mass index (BMI) between 18.5 and 28 kg/m^2, and be classified as ASA (American Society of Anesthesiologists) physical status class II.

Exclusion criteria

Exclusion criteria: 1. Individuals with psychiatric disorders such as schizophrenia or mania; those on long-term medication with anesthetics, Schedule I controlled substances, or Schedule II controlled substances; individuals with cognitive impairment or hearing impairment; and those unable to cooperate with the examination. 2.Patients with significant preoperative respiratory dysfunction, such as obstructive sleep apnea syndrome, acute respiratory tract infection, acute exacerbation of chronic obstructive pulmonary disease, or uncontrolled asthma. Patients assessed as having difficult airway management: Modified Mallampati Score of III or IV. 3.Patients with significant preoperative circulatory dysfunction, such as New York Heart Association (NYHA) functional class III or IV, unstable angina, myocardial infarction within 6 months prior to surgery, third-degree atrioventricular block, or moderate to severe valvular heart disease. 4.Patients with significant preoperative liver or kidney disease and coagulation disorders. 5.Patients with limited head extension, cervical spine immobility, ankylosing spondylitis, or myasthenia gravis. 6. Patients with a history of long-term smoking, alcohol abuse, or diabetes. 7.Patients with known allergy or contraindication to the study drugs (e.g., alfentanil hydrochloride injection, propofol injection) or their components. 8. Patients currently participating in other clinical trials. 9.Patients deemed unsuitable for this trial by the investigator. 10. Patients who voluntarily withdraw from the trial, refuse participation, or decline follow-up.

Design outcomes

Primary

MeasureTime frame
Incidence of mandibular displacement;Time points (including induction time, surgical time, recovery time, and PACU recovery time);Dosage;

Secondary

MeasureTime frame
Sedation success rate;Perioperative vital signs and OAA/S score;Pain Scores (Including injection pain at anesthesia initiation, postoperative uterine contraction pain, postoperative day 1 uterine contraction pain);Satisfaction scores of gynecologists, anesthesiologists, and patients;

Countries

China

Contacts

Public ContactLiu Jie

The Second Hospital of Dalian Medical University

bianyuqing2022@163.com+86 183 0492 4736

Outcome results

None listed

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