Postoperative Pain in Gynecological Diseases
Conditions
Interventions
Tegileridine PCIA (Experimental Group):Tygeidine was administered intravenously 1mg once after surgery, and 10min after the first dose, subjects could self-administer Tygelidine injection on demand th
Sufentanil PCIA (Control Group):Sufentanil was given a single intravenous dose of 2 µg after surgery, and a PCA dose of 2 µg of sufentanil could be used after receiving the initial dose for 10 minutes
Sponsors
Ruijin hospital, Shanghai
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Undergo elective (before 14:00 p.m.) gynecological laparoscopic surgery under general anesthesia; 2. 18 years old< = age< = 65 years old; 3. 18 kg/m^2<=BMI<=30 kg/m^2; 4. American Society of Anesthesiologists (ASA) grade I.~III; 5. Before starting the trial-related activities, voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and voluntarily comply with this trial process.
Exclusion criteria
Exclusion criteria: 1. History of severe cardiovascular or cerebrovascular diseases; 2. Comorbid psychiatric disorders or cognitive dysfunction; 3. History of severe respiratory depression or bronchial asthma; 4. Known or suspected gastrointestinal obstruction (including paralytic ileus); 5. Sensory disorders (e.g., hyperalgesia) or pre-existing somatic pain interfering with postoperative pain assessment; 6. Severe hepatic insufficiency; 7. Any other condition deemed by investigators to contraindicate participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of nausea and vomiting (PONV) within 24 hours after surgery (as counted in patients with nausea or vomiting); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of respiratory depression (respiratory depression defined as respiratory rate < 8 breaths per minute and/or oxygen saturation <90%) within 24 h after surgery;NRS score at 1, 3, 6, 12, 24 h after a single intravenous dose;Time to first use of salvage analgesic medication after a single intravenous dose;Sleep efficiency (sleep time/total time spent in bed) and sleep structure (N1, N2, N3 sleep ratio) the night before surgery and the night after surgery;Time to first pass gas (from the end of surgery).;Time to first get out of bed (until the end of surgery).;Total length of hospital stay (until the end of surgery).;Subject analgesia satisfaction score;Investigator analgesia satisfaction score;Proportion of subjects using salvage analgesia within 24 hours after a single intravenous dose;The number of salvage analgesia within 24 hours after a single intravenous dose;Cumulative use of salvage analgesic drugs within 24 hours after a single intravenous administration;Pittsburgh Sleep Quality Index (PSQI) score the night before surgery and the night after surgery; | — |
Countries
China
Contacts
Public ContactHui Zhang;Yang Qian
Shanghai Ruijin Hospital
Outcome results
None listed