Hysteroscopic Surgery
Conditions
Interventions
Phase 1: Control Group (Group F):Fentanyl combined with propofol
Phase 2: Control Group (Group F):Fentanyl combined with propofol
Phase I: Experimental Group (Group T):Tapentadol fumarate combined with propofol
Phase 2: Experimental Group (Group F):Tapentadol fumarate combined with propofol
Sponsors
First Affiliated Hospital of Gannan Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Scheduled to undergo hysteroscopic surgery; 2. Aged 18 to 65 years (inclusive); 3. Body mass index (BMI) between 18 and 28 kg/m² (inclusive); 4. American Society of Anesthesiologists (ASA) physical status classification I-II; 5. Willing to provide written informed consent before participating in trial-related activities, with full understanding of the trial's purpose and significance, and voluntarily agrees to comply with all trial procedures;
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to opioids, propofol, or any components of the investigational drug; 2. Patients with severe cardiac, hepatic, or renal dysfunction; 3. Recent (within 2 weeks) respiratory tract infection; 4. Pregnant or lactating women; 5. Patients with a history of difficult airway (e.g., obstructive sleep apnea syndrome), severe respiratory depression (oxygen saturation <90%), or acute/severe bronchial asthma; 6. Participation in other drug clinical trials within the past 3 months; 7. History of severe psychiatric disorders or substance dependence; 8. Known or suspected gastrointestinal obstruction, including paralytic ileus; 9. Subjects deemed by investigators to have any other conditions unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 95% effective dose (ED95) of tegileridine fumarate combined with propofol for hysteroscopic surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative adverse event rate;Postoperative NRS score;Hemodynamic parameters (blood pressure and heart rate) at each time point;Incidence of perioperative respiratory depression;Incidence of postoperative nausea and vomiting (PONV); | — |
Countries
China
Contacts
Public ContactHouren Xu
First Affiliated Hospital of Gannan Medical University
Outcome results
None listed