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Observation of the Anesthetic Effects of Anrikefon or Sufentanil Combined with Propofol in Hysteroscopic Surgery: A Prospective, Single-Center, Blinded, Randomized Controlled Trial

Observation of the Anesthetic Effects of Anrikefon or Sufentanil Combined with Propofol in Hysteroscopic Surgery: A Prospective, Single-Center, Blinded, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119692
Enrollment
Unknown
Registered
2026-03-02
Start date
2026-03-02
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Hysteroscopic surgery pain

Interventions

The Anrelifin combined with propofol group (Group A):Anrekefen (ED95 dose determined by pre-experiment, intravenous push over 2 minutes) + Propofol (intravenous push at 2mg/kg, followed by TCI mainten
Sufentanil combined with propofol group (Group S):Sufentanil (0.15µg/kg, intravenous push over 2 minutes) + Propofol (intravenous push at 2mg/kg, followed by TCI maintenance target concentration of 4µ

Sponsors

The First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Females aged between 18 and 65 years; 2.Subjects in good or relatively good health (American Society of Anesthesiologists physical status classification Class I–II); 3.Scheduled to undergo hysteroscopic surgery at the First People's Hospital of Yunnan Province; 4.Voluntarily agree to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Known allergy to opioids, propofol, or anrikefon; 2.Allergy to high-protein foods such as soybeans or milk; 3.Long-term use of opioid or non-steroidal anti-inflammatory drugs for analgesia (three or more times per week); 4.Severe cardiac, pulmonary, hepatic, or renal dysfunction; 5.Difficult airway, uncontrolled hypertension, or severe arrhythmia; 6.History of substance abuse or dependence; 7.Women who are pregnant or breastfeeding; 8.Presence of mental or cognitive impairment that prevents cooperation with study assessments.

Design outcomes

Primary

MeasureTime frame
Median effective dose (ED50) and its 95% confidence interval; 95% effective dose (ED95);Postoperative VAS pain score;

Secondary

MeasureTime frame
Rescue analgesia rate; mean consumption of analgesic drugs (flurbiprofen axetil);Incidence of hypoxemia;Hemodynamic parameters (SBP, DBP, MAP, HR) and incidence of adverse events (hypotension, hypertension, bradycardia, tachycardia);Incidence of postoperative nausea and vomiting (PONV);PACU stay duration;Incidence of postoperative dizziness/sedation and skin pruritus;Satisfaction score;Postoperative vaginal blood loss volume;

Countries

China

Contacts

Public ContactJing Luo

The First People's Hospital of Yunnan Province

2292940670@qq.com+86 180 8798 8614

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026