Surgery · Medical Literature
Tegileridine versus Sufentanil Patient-Controlled Intravenous Analgesia for Gastrointestinal Recovery in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial.
Abstract
To compare tegileridine-based and sufentanil-based patient-controlled intravenous analgesia (PCIA) for postoperative gastrointestinal recovery in elderly patients undergoing laparoscopic colorectal cancer surgery. In this single-center, double-blind, randomized controlled trial, patients scheduled for elective laparoscopic colorectal cancer surgery were randomized 1:1 to tegileridine-based PCIA (Group T) or sufentanil-based PCIA (Group S). The primary outcome was the Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms (I-FEED) score on postoperative day 3 (POD3). Secondary outcomes included I-FEED scores on POD1-5 (excluding POD3), incidence of postoperative gastrointestinal dysfunction (POGD), time to first flatus and defecation, analgesic outcomes, quality of recovery, and adverse events. One hundred patients were included in the primary analysis (Group T, n = 51; Group S, n = 49). Compared with Group S, Group T had significantly lower I-FEED scores on POD1 (estimated marginal mean [EMM] difference, -0.60; 95% CI, -1.03 to -0.17; P = 0.006), POD2 (EMM difference, -0.66; 95% CI, -1.14 to -0.18; P = 0.008), and POD3 (EMM difference, -0.72; 95% CI, -1.17 to -0.27; P = 0.002), a lower incidence of POGD (11.8% vs 28.6%; P = 0.036), and a shorter time to first flatus (36 h vs 40 h; P = 0.025). Pain scores, PCIA use, and rescue analgesia were comparable between groups. Quality of Recovery-15 (QoR-15) scores were higher in Group T on POD2 and POD3. Group T also had a lower overall incidence of adverse events (27.5% vs 49.0%; P = 0.027) and a lower incidence of nausea and vomiting (23.5% vs 44.9%; P = 0.024). In elderly patients undergoing laparoscopic colorectal cancer surgery, tegileridine-based PCIA provided analgesia comparable to sufentanil under the prespecified dosing regimens. It was associated with better gastrointestinal recovery during the first three postoperative days and fewer adverse events. This regimen may be a safe and effective analgesic option in this population.
Clinical relevance
Postoperative gastrointestinal dysfunction (POGD) is a clinically significant complication in elderly patients undergoing laparoscopic colorectal cancer surgery, prolonging hospitalization and delaying return to baseline function. Sufentanil-based PCIA, while effective for analgesia, carries well-recognized opioid-related gastrointestinal side effects that are particularly burdensome in this vulnerable population. This RCT addresses the unmet need for an opioid-based PCIA regimen that preserves analgesic efficacy while mitigating gastrointestinal morbidity in elderly surgical oncology patients.
Key findings
1. Primary outcome — I-FEED score on POD3: Tegileridine-based PCIA produced significantly lower I-FEED scores compared with sufentanil (EMM difference, −0.72; 95% CI, −1.17 to −0.27; P = 0.002), indicating superior early gastrointestinal recovery. 2. I-FEED scores on POD1 and POD2: The gastrointestinal benefit was consistent across earlier postoperative days — POD1 (EMM difference, −0.60; 95% CI, −1.03 to −0.17; P = 0.006) and POD2 (EMM difference, −0.66; 95% CI, −1.14 to −0.18; P = 0.008). 3. Incidence of POGD: Significantly lower in Group T versus Group S (11.8% vs 28.6%; P = 0.036), representing a clinically meaningful absolute risk reduction of 16.8 percentage points. 4. Time to first flatus: Statistically shorter in the tegileridine group (36 h vs 40 h; P = 0.025), reflecting faster return of bowel motility. 5. Analgesic non-inferiority: Pain scores, PCIA consumption, and rescue analgesia requirements were comparable between groups, confirming that gastrointestinal benefits were not achieved at the cost of analgesic efficacy. 6. Safety profile: Tegileridine was associated with a significantly lower overall incidence of adverse events (27.5% vs 49.0%; P = 0.027) and a lower incidence of nausea and vomiting specifically (23.5% vs 44.9%; P = 0.024); Quality of Recovery-15 (QoR-15) scores were also superior in Group T on POD2 and POD3.
Practice implications
In elderly patients undergoing elective laparoscopic colorectal cancer surgery, tegileridine-based PCIA should be considered as a preferred alternative to sufentanil-based PCIA given its comparable analgesic efficacy coupled with significantly reduced rates of POGD, nausea/vomiting, and overall adverse events under the prespecified dosing regimens used in this trial. Clinicians implementing this regimen should monitor I-FEED scores on POD1–3 as a structured surveillance tool to identify early gastrointestinal dysfunction and guide escalation of care. Given the single-center design and the specific elderly colorectal oncology population studied, generalizability should be confirmed in multicenter trials before broad adoption across other surgical subspecialties or age groups.