Gastroenterology · Medical Literature
Safety and Efficacy of Oliceridine Combined with Propofol for Painless Gastroscopy: A Single-Center, Randomized, Parallel Controlled Clinical Trial.
Abstract
To explore the safety and efficacy of the novel G protein-biased μ-opioid receptor agonist oliceridine for painless gastroscopy. This study is a single-center randomized controlled clinical trial. One hundred and eighty-eight patients scheduled for painless gastroscopy were randomly assigned to four groups: Group L (oliceridine 10 μg/kg + propofol 2mg/kg), Group M (oliceridine 20 μg/kg + propofol 2mg/kg), Group H (oliceridine 30 μg/kg + propofol 2mg/kg) and Group C (sufentanil 0.1 μg/kg + propofol 2mg/kg). The primary outcome was the incidence of respiratory depression. Secondary outcomes included the incidence of respiratory arrest, bradypnea (respiratory rate<8 bpm) and hypoxemia (pulse oxygen saturation (SpO2) < 90%). Other outcomes included procedure and sedation-related outcomes, perioperative vital signs and adverse effects were recorded. Among the 184 patients, 46, 46, 45 and 47 patients were randomly assigned to the L, M, H and C groups, respectively, and completed the trial. The incidence of respiratory depression in Group C (55.32%) and Group H (46.67%) was significantly higher than that in Group L (15.22%) and Group M (17.39%) (P<0.05). The incidence of respiratory arrest was higher in group H (42.22%) and group C (51.06%) compared to group L (13.04%) and group M (15.22%) (P < 0.05). The incidence of bradypnea and hypoxemia in group C (31.90% and 14.89%) was higher than that in group M (6.5% and 0) (P < 0.05). The sedation success rate was significantly lower in Group L than in Group M (71.74% vs 93.48%; P < 0.05). No significant differences were observed in the incidence of postoperative adverse effects. 10 μg/kg and 20 μg/kg oliceridine is associated with a reduced risk of respiratory depression when co-administered with propofol for painless gastroscopy in adults, and the 20 μg/kg oliceridine exhibits superior sedative efficacy.
Clinical relevance
Does oliceridine (a G protein-biased μ-opioid receptor agonist) at low (10 μg/kg), medium (20 μg/kg), or high (30 μg/kg) doses combined with propofol 2 mg/kg reduce respiratory depression compared to sufentanil 0.1 μg/kg combined with propofol 2 mg/kg during painless gastroscopy in adults? __SNAPSHOT__ {"studyDesign":"Single-center, randomized, parallel-controlled clinical trial (four-arm)","setting":"Single center, People's Republic of China (Dazhou, Sichuan); institution type not explicitly reported beyond a single clinical site","sampleSize":"n=188 enrolled; n=184 completed (Group L: 46, Group M: 46, Group H: 45, Group C [sufentanil comparator]: 47)","population":"Adult patients scheduled for elective painless gastroscopy; ASA physical status, BMI range, and age bounds not fully detailed in the available abstract","intervention":"Oliceridine at three weight-based doses — 10 μg/kg (Group L), 20 μg/kg (Group M), and 30 μg/kg (Group H) — each combined with propofol 2 mg/kg for procedural sedation","comparator":"Sufentanil 0.1 μg/kg + propofol 2 mg/kg (Group C); active comparator reflecting current guideline-recommended sedation regimen for painless gastroscopy","primaryOutcome":"Incidence of respiratory depression during the procedure","followUp":"Perioperative period; exact post-procedure follow-up duration not reported in the abstract","fundingSource":"Not reported"}
Key findings
Primary outcome — respiratory depression: Incidence was significantly lower in Group L (15.22%) and Group M (17.39%) compared to Group H (46.67%) and Group C/sufentanil (55.32%) (P <0.05 for pairwise comparisons between low/medium oliceridine groups and high oliceridine/sufentanil groups; specific confidence intervals not reported). The absolute risk reduction (ARR) for Group M vs. Group C is approximately 37.9% (calculated), yielding a number needed to treat (NNT) of approximately 3 (calculated) to prevent one case of respiratory depression. Secondary respiratory outcomes: The incidence of respiratory arrest was also significantly higher in Group H (42.22%) and Group C (51.06%) compared to Group L (13.04%) and Group M (15.22%) (P <0.05). Bradypnea (RR <8 bpm) and hypoxemia (SpO₂ <90%) were significantly more frequent in Group C (31.90% and 14.89%, respectively) than in Group M (6.5% and 0%) (P <0.05); comparisons involving Groups L and H for these endpoints are not fully detailed in the available abstract. Sedation efficacy: The sedation success rate in Group L (71.74%) was significantly lower than in Group M (93.48%) (P <0.05), indicating inadequate procedural sedation at the lowest oliceridine dose. Postoperative adverse effects: No statistically significant differences were observed across groups in the incidence of postoperative adverse effects. Specific effect sizes, confidence intervals, and p-values beyond those noted above were not reported in the abstract.
Practice implications
This trial establishes that oliceridine at 10 μg/kg and 20 μg/kg, when combined with standard propofol 2 mg/kg, is associated with substantially lower rates of respiratory depression, respiratory arrest, bradypnea, and hypoxemia compared to sufentanil 0.1 μg/kg plus propofol in the setting of adult painless gastroscopy. The 20 μg/kg dose appears to represent the most favorable benefit-risk profile among tested doses, offering both high sedation success (93.48%) and low respiratory depression (17.39%). The 10 μg/kg dose, while safer, demonstrated inadequate sedation success (71.74%), limiting its clinical utility as a standalone induction regimen. The high oliceridine dose (30 μg/kg) did not confer a respiratory safety advantage over sufentanil, suggesting a dose-dependent β-arrestin-mediated respiratory liability that partially negates the mechanistic benefit of G protein bias at higher doses. Findings appear clinically important given the high baseline incidence of respiratory depression with sufentanil (55.32%) and the frequency with which this complication is encountered in endoscopy units. However, generalizability is constrained by the single-center design, restriction to adult elective gastroscopy patients (geriatric, pediatric, high-ASA, and obese populations are not adequately represented), and the absence of detail on pre-oxygenation protocols, rescue interventions, and capnography monitoring. As only the abstract is available for review, full assessment of randomization concealment, blinding procedures, statistical methods, and secondary outcome reporting is not possible. The findings are hypothesis-confirming for oliceridine's mechanistic rationale but require multi-center replication before adoption as a preferred sedation regimen. __LIMITATIONS__ Single-center design limits generalizability across endoscopy practice settings and patient populations.,Only the abstract was available for review; full methodological details (randomization concealment, blinding strategy, power calculation, rescue protocols) cannot be assessed.,No confidence intervals are reported for any outcome; statistical significance is conveyed only by 'P <0.05', limiting precision of effect estimates.,Blinding status of anesthesiologists, endoscopists, and outcome assessors is not specified in the abstract, raising risk of performance and detection bias.,Propofol dose was fixed at 2 mg/kg across all groups, which may not reflect titrated clinical practice and could amplify respiratory depression in the comparator arm if doses were not individually optimized.,The specific sufentanil dose chosen (0.1 μg/kg) may represent a relatively high dose for some patient subgroups, potentially biasing respiratory outcome comparisons in favor of oliceridine.,Short procedural duration (typically 2–10 minutes) limits assessment of recovery-phase adverse events and longer-term safety outcomes.,Postoperative adverse effect data lack granularity; nausea, vomiting, pruritus, and dizziness rates are not individually reported.,High-risk subgroups (elderly, obese, ASA III–IV, sleep apnea) are not identified or separately analyzed.,Funding source is not reported, precluding assessment of potential industry sponsorship bias.,Statistical comparison between Group L and Group H, and between Group H and Group M, for all secondary respiratory endpoints are not clearly reported in the abstract. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ Oliceridine 20 μg/kg combined with propofol 2 mg/kg achieves high sedation success (93.48%) with markedly reduced respiratory depression (17.39%) compared to sufentanil 0.1 μg/kg plus propofol (55.32%) in adult painless gastroscopy, with an NNT of approximately 3 (calculated) to prevent one episode of respiratory depression. The 10 μg/kg dose is safer still but carries an unacceptably low sedation success rate (71.74%), while the 30 μg/kg dose loses the respiratory safety advantage. These results are promising and pharmacologically plausible, but single-center scope, abstract-only data availability, and absence of confidence intervals necessitate multi-center confirmation before oliceridine 20 μg/kg can be routinely recommended as a sufentanil replacement in procedural gastroscopy sedation.