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This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegileridine Group | Experimental | Participants in this group will receive postoperative patient-controlled intravenous analgesia containing tegileridine 5 mg and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes. |
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| Sufentanil Group | Active Comparator | Participants in this group will receive postoperative patient-controlled intravenous analgesia containing sufentanil 100 micrograms and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegileridine | Drug | Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU | The cumulative resting pain score within 24 hours after admission to the post-anesthesia care unit (PACU) will be represented by the area under the curve of the numeric rating scale (NRS) scores from 0 to 24 hours. Resting pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be measured at 0, 6, 12, 18, and 24 hours after admission to the PACU. | From 0 to 24 hours after admission to the PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Resting and Movement Pain Intensity | Resting and movement pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be recorded at 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU. | At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Inflammatory Biomarkers | Serum levels of inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha), will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on systemic inflammatory response. | Before surgery and at predefined time points within 72 hours after admission to the PACU |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihong Jiang, MD | Contact | 86-13482002227 | jiangjihong@outlook.com | |
| Jie Xiao | Contact | 86-18353689295 | XiaoJie20220747@163.com |
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Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.
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Participants will be randomly assigned in a 1:1 ratio to either the tegileridine group or the sufentanil group for postoperative patient-controlled intravenous analgesia.
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Participants, care providers, and outcomes assessors will be blinded to group allocation. Study drugs will be prepared and labeled by personnel not involved in postoperative care or outcome assessment to maintain blinding.
| Sufentanil | Drug | Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery. |
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| Palonosetron | Drug | Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis. |
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| PCIA Demand and Effective Press Counts | Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU. | Within 48 hours after admission to the PACU. |
| Use of Rescue Analgesia | The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU. | Within 72 hours after admission to the PACU |
| Incidence and Severity of PONV | The incidence and severity of postoperative nausea and vomiting (PONV) will be assessed using a standardized nausea and vomiting assessment scale within 72 hours after admission to the PACU. | Within 72 hours after admission to the PACU |
| Time to First Flatus | Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus. | From admission to the PACU until first passage of flatus, assessed up to 1 week. |
| Time to First Bowel Movement | Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement. | From admission to the PACU until first bowel movement, assessed up to 1 week. |
| Time to Resumption of Oral Intake | Time to resumption of oral intake will be defined as the time from admission to the PACU to the first postoperative intake of liquids, semi-liquid food, or regular diet. | From admission to the PACU until resumption of oral intake, assessed up to 1 week. |
| Length of Postoperative Hospital Stay | Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge. | From admission to the PACU until hospital discharge, assessed up to 30 days. |
| Changes in I-FABP | Serum intestinal fatty acid-binding protein (I-FABP) levels will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on intestinal injury. | Before surgery and at predefined time points within 72 hours after admission to the PACU |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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