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The safety and efficacy of alfentanil-propofol combined total intravenous anesthesia without neuromuscular blocking agents during daytime hysteroscopy induction and maintenance

The safety and efficacy of alfentanil-propofol combined total intravenous anesthesia without neuromuscular blocking agents during daytime hysteroscopy induction and maintenance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096870
Enrollment
Unknown
Registered
2025-02-08
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Quality of anesthesia recovery

Interventions

NMBA Group(Experiment 1):cisatracurium 0.1mg/kg
Compare Group(Experiment 1):0.9% normal saline solution with equivalent volume of cisatracurium in the NMBA group
A1 Group(Experiment 2): Propofol 3.0 µg/mL TCI + Alfentanil 5 ug/kg
A2 Group(Experiment 2): Propofol 2.5 µg/mL TCI + Alfentanil 10 ug/kg
A3 Group(Experiment 2): Propofol 2.0 µg/mL TCI + Alfentanil 15 ug/kg

Sponsors

Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age range: 18-65 years old; ASA Grading I-II; Proposed day hysteroscopic surgery under general anesthesia; No other serious systemic comorbidities; Conscious and able to cooperate with examination and treatment; Patient informed consent, and signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to the drugs used in this study, such as alfentanil, fentanyl, sufentanil, propofol, etc.; 2. Perennial alcohol craving, long-term use of drugs that affect mental state (such as sedatives) and monoamine oxidase inhibitors; 3. ASA classification greater than grade II; 4. Patients with severe liver dysfunction (such as Child-Pugh class C) or abnormal renal function (such as preoperative dialysis); 5. Arrhythmia, preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats/min) or grade II or above atrioventricular block, with pacemaker installed; 6. Cognitive impairment due to mental and psychological disorders.

Design outcomes

Primary

MeasureTime frame
VAS score of intraoperative body movement(Experiment 1);Duration from completion of surgery to Aldrete score = 9(Experiment 2);

Secondary

MeasureTime frame
Anesthesia induction time(Experiment 1);Time for insertion of laryngeal mask(Experiment 1);Airway pressure before inflation when laryngeal mask is inserted(Experiment 1);Airway pressure after inflation when laryngeal mask is inserted(Experiment 1);Patient's depth of sedation after surgery(Experiment 2);Time from completion of surgery to removal of laryngeal mask(Experiment 2);Incidence of intraoperative hypotension(Experiment 2);Incidence of bradycardia during surgery(Experiment 2);Postoperative recovery quality(Experiment 2);

Countries

China

Contacts

Public ContactJianjun Li

Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University

ljj9573@163.com+86 185 6181 1399

Outcome results

None listed

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