Postoperative Pain
Conditions
Interventions
A single-group dose-exploration study using the modified Dixon sequential method:Intravenous injection of tegilitidine, with doses adjusted according to sequential rules.
Sponsors
Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years; 2. Scheduled for elective laparoscopic cholecystectomy; 3. ASA class I–II; 4. Able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Long-term opioid users (>=3 months); 2. Patients with opioid allergies or contraindications; 3. Severe hepatic or renal insufficiency; 4. Pregnant or lactating women; 5. Patients with severe respiratory diseases; 6. Individuals unable to cooperate with pain assessment or follow-up; 7.Participants in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The median effective dose (ED 50) and 95% effective dose (ED 95) of tegildine for early postoperative analgesia after laparoscopic cholecystectomy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain assessment using the Numeric Rating Scale (NRS) at 1, 3, and 6 hours after extubation.;Usage of postoperative opioid rescue analgesics.; | — |
Countries
China
Contacts
Public ContactWang lanlan
Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed