Gynecological uterine diseases
Conditions
Interventions
Experimental group:Postoperative analgesia: Tigillitin fumarate is prepared at 0.05mg/ml
Control group:Postoperative analgesia: Sufentanil is prepared at 5ug/ml
Sponsors
Liaocheng Second People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 40-60 years. 2. American Society of Anesthesiologists (ASA) physical status I-II. 3. Body mass index (BMI) ranging from 18 to 28 kg/m². 4. Scheduled for elective gynecological laparoscopic hysterectomy. 5. Patients provided informed consent, agreed to use a patient-controlled analgesia (PCA) pump postoperatively, were willing to accept follow-up, and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational drugs (Taijiliding, Sufentanil) or any of their components. 2. Severe cardiac, pulmonary, hepatic, or renal insufficiency (e.g., LVEF <50%, creatinine clearance <30 ml/min) or presence of neurological diseases. 3. Long-term use of opioid analgesics or sedative medications, or a history of drug abuse/dependence. 4. Participation in other drug clinical trials within the past 1 month. 5. Communication barriers or psychiatric disorders that prevent cooperation with pain assessment. 6. Patients with severe respiratory depression, such as oxygen saturation below 90%. 7. Acute or severe bronchial asthma patients in settings without vital sign monitoring or life resuscitation equipment. 8. Known or suspected gastrointestinal obstruction, including paralytic ileus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 15-item Postoperative Recovery Quality Scale (QoR-15) score at 48 hours after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative 24-hour (QoR-15) score;The time of the first postoperative ambulation, the time of the first defecation, and the postoperative hospital stay;The resting and movement (coughing) VAS pain scores at 2 hours, 6 hours, 24 hours, and 48 hours after the operation;The number of times the analgesic pump was pressed within 48 hours after the operation;Dosage of medication;Adverse events within 48 hours after the operation; | — |
Countries
China
Contacts
Public ContactZhang Zhimei
Liaocheng Second People's Hospital
Outcome results
None listed