Tegileridine versus Sufentanil Patient-Controlled Intravenous Analgesia for Gastrointestinal Recovery in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial.
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.
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.