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Efficacy and Safety of Fumaric Acid Tylenol Compared with Sufentanil for Postoperative Patient-Controlled Analgesia in Patients Undergoing Laparoscopic Hysterectomy : A Randomized, Double-Blind, Non-Inferiority Trial

Efficacy and Safety of Fumaric Acid Tylenol Compared with Sufentanil for Postoperative Patient-Controlled Analgesia in Patients Undergoing Laparoscopic Hysterectomy : A Randomized, Double-Blind, Non-Inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106253
Enrollment
Unknown
Registered
2025-07-21
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Gynecologic laparoscopic total hysterectomy

Interventions

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~65 years old; 2. ASA grading I~III. 3. BMI 18~30 kg/m^2; 4. Intended to undergo gynecological laparoscopic total hysterectomy under general anesthesia; 5. Self-controlled intravenous analgesic pump is required after surgery; 6. Know the content of the study and voluntarily sign the informed consent form for the study.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of previous difficult airway (e.g., obstructive sleep apnea syndrome), severe respiratory depression (e.g., oxygen saturation <90%), or acute or severe bronchial asthma; 2. Patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina, or severe arrhythmia, such as atrioventricular block of the second degree or above, or ischemic stroke of NYHA class II or above); 3. Patients with known or suspected gastrointestinal obstruction, including paralytic ileal obstruction; 4. Patients who are hypersensitive to opioids or any component of the trial drug; 5. Subjects who have had psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment or inability to communicate; 6. Patients with advanced malignant tumors or malignant tumors with extensive metastasis; 7. Subjects with other somatic pain that may affect postoperative pain assessment; 8. Patients with known severe hepatic dysfunction (Childe-Pugh class C); 9. History of drug abuse, alcohol abuse and/or drug abuse within 1 year prior to randomization; 10. Pregnant or lactating female subjects; 11. Subjects who, in the opinion of the investigator, are not eligible to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Pain scores;

Secondary

MeasureTime frame
Postoperative nausea and vomiting;Quality of intra-patient recovery 48h after surgery;

Countries

China

Contacts

Public ContactMei Bin

The First Affiliated Hospital of Anhui Medical University

mb85doc@yeah.net+86 135 0560 3810

Outcome results

None listed

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