Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Title: Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery: A Multicenter, Randomized, Controlled Trial
The goal of this clinical trial is to evaluate the effectiveness and safety of tegileridine, a biased μ-opioid receptor agonist, for patient-controlled intravenous analgesia (PCIA) after abdominal surgery.
The main question it aims to answer is:
Is tegileridine superior to morphine in promoting the recovery of gastrointestinal function within 72 hours after abdominal surgery?
Researchers will compare the experimental group (receiving Fumarate Tegileridine Injection) to the active control group (receiving Morphine Hydrochloride Injection). Both groups will also receive dexmedetomidine in their PCIA pumps. This comparison will determine if tegileridine is more effective for bowel recovery and has a better safety profile.
Participants who are scheduled for elective abdominal surgery under general anesthesia will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegileridine PCIA Group | Experimental |
| |
| Morphine PCIA Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegileridine | Drug | Participants in this arm will receive postoperative analgesia via a Patient-Controlled Intravenous Analgesia (PCIA) pump containing a sterile solution. The pump is filled with a 100 mL mixture of the investigational drug, Tegileridine Fumarate Injection, at a concentration of 0.05 mg/mL, and the adjuvant drug, Dexmedetomidine Hydrochloride Injection, at 2 μg/mL. The PCA pump is programmed with no continuous background infusion (0 mL/h). A loading dose of 20 mL is administered at the start. Thereafter, participants can self-administer a 4 mL bolus on-demand for pain relief, with a maximum allowable dose of 12 mL per hour and a lockout interval of 10 minutes between boluses. This intervention is planned for a duration of 72 hours following abdominal surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with recovery of gastrointestinal function within 72 hours post-surgery. | Gastrointestinal function recovery is defined by the GI-3 composite endpoint: the ability to tolerate solid food (time to first tolerance of solid food) AND having either flatus (time to first flatus) or bowel movement (time to first bowel movement). The proportion is calculated as the number of participants who meet this composite endpoint within 72 hours after surgery divided by the total number of participants analyzed. | Within 72 hours after abdominal surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to GI-3 recovery. | The time (in hours) from the end of surgery until the participant first meets the GI-3 composite endpoint (tolerating solid food AND having flatus or bowel movement). | From end of surgery up to 7 days postoperatively. |
| Time to first tolerance of solid food. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Longyan Li, M.D., Ph.D. | Contact | +86-15273139192 | lilongyan206@csu.edu.cn | |
| Lirui Xian, M.B. | Contact | +86-19198053454 | xianlirui123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zongbin S. Song, M.D., Ph.D. | Xiangya Hospital of Central South University | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Morphine | Drug | Participants in this arm will receive postoperative analgesia via a Patient-Controlled Intravenous Analgesia (PCIA) pump containing a sterile solution. The pump is filled with a 100 mL mixture of the active comparator drug, Morphine Hydrochloride Injection, at a concentration of 0.25 mg/mL, and the same adjuvant drug, Dexmedetomidine Hydrochloride Injection, at 2 μg/mL. The PCA pump parameters are identical to Arm 1: no continuous background infusion (0 mL/h), a 20 mL loading dose, a 4 mL on-demand bolus dose, a maximum limit of 12 mL per hour, and a 10-minute lockout interval. This intervention is also planned for a duration of 72 hours post-surgery. The sole distinction between the two arms is the core analgesic agent (Tegileridine vs. Morphine) within the otherwise identical PCIA regimen. |
|
The time (in hours) from the end of surgery until the participant first tolerates solid food. |
| From end of surgery up to 7 days postoperatively. |
| Time to first flatus. | The time (in hours) from the end of surgery until the participant has the first passage of flatus. | From end of surgery up to 7 days postoperatively. |
| Overall Benefit of Analgesia Score (OBAS). | The OBAS is a composite score (range 0-28) assessing pain at rest, opioid-related side effects (vomiting, pruritus, sweating, shivering, dizziness), and satisfaction with analgesia. A lower score indicates a higher overall benefit. It will be assessed at 24h, 48h, and 72h postoperatively. | At 24, 48, and 72 hours postoperatively. |
| Quality of Recovery-15 (QoR-15) Score. | The QoR-15 is a 15-item patient-reported questionnaire assessing the quality of recovery after anesthesia and surgery. Total scores range from 0 (extremely poor quality of recovery) to 150 (extremely high quality of recovery). | At 24 hours postoperatively. |
| Time to meet criteria for hospital discharge. | The time (in hours) from the end of surgery until the participant meets the standard discharge criteria of the participating center, as determined by the attending physician. | From end of surgery through study completion, an average of 7 days. |
| Richards-Campbell Sleep Questionnaire (RCSQ) Score. | The RCSQ is a 5-item visual analog scale assessing nighttime sleep quality, including depth of sleep, sleep latency, awakenings, ease of returning to sleep, and overall sleep quality. Each item scores 0-100, and the mean of the five items is the total score, with higher scores indicating better sleep quality. | Daily from postoperative day 1 to postoperative day 3 (assessing the previous night's sleep). |
| Resting pain assessed by Numerical Rating Scale (NRS). | Pain intensity at rest will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable". | At 24, 48, 72 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |