Intraoperative Target-Controlled Infusion of Sufentanil versus Standard Fentanyl for 24‑hour Postoperative Analgesia in Urgent Laparoscopic Cholecystectomy

The primary objective is to assess whether intra‑operative administration of sufentanil via a target‑controlled infusion is non‑inferior to standard fentanyl practice for postoperative analgesia within the first 24 hours after urgent laparoscopic cholecystectomy, using the visual analogue scale (VAS) as the efficacy endpoint. Secondary objectives include:

• Characterization of the clinical and sociodemographic profile of the enrolled cohort;
• Comparison of pain intensity between groups at 1, 2 and 12 hours post‑operatively;
• Estimation of intra‑group differences in pain scores at the same time points;
• Comparison of the total administered opioid dose (sufentanil or fentanyl) in micrograms;
• Comparison of cumulative rescue opioid requirement (morphine‑equivalent mg) during the first 24 hours;
• Assessment of time to first request for additional analgesia;
• Comparison of the incidence of opioid‑related adverse events (nausea, vomiting, respiratory depression, pruritus);
• Evaluation of the administered dose of each study drug.

Participants were adult patients (≥18 years) of both sexes scheduled for urgent laparoscopic cholecystectomy. Eligibility required an American Society of Anesthesiologists (ASA) classification of I, II, or III and provision of written informed consent. The trial population was drawn from individuals meeting these criteria at the study site; no additional lifestyle restrictions such as specific diet or physical activity levels were stipulated. The sponsor did not provide information on the total number of participants enrolled. Key inclusion elements included age, ASA status, urgency of the surgical procedure, and consent; specific exclusion criteria were not disclosed.

The study is a controlled comparative trial evaluating intra‑operative administration of sufentanil (75 µg IV bolus/infusion) versus standard practice administration of fentanyl (750 µg IV bolus/infusion) in patients undergoing urgent laparoscopic cholecystectomy. Eligible participants are adults (≥18 years) with ASA classification I–III who provide informed consent. After a screening visit to confirm eligibility, participants receive the assigned investigational medication using a concentration‑targeted continuous intravenous infusion model during surgery. Post‑operative pain is assessed with the primary endpoint, the Visual Analogue Scale (VAS), recorded at the first, second, and twelfth postoperative hours, and overall analgesic consumption within the first 24 hours. Secondary assessments include demographic variables, ASA status, incidence of nausea, vomiting, pruritus, respiratory depression, intra‑operative opioid dose, and total opioid use in the first day. Follow‑up visits occur at the specified postoperative time points, culminating in an end‑of‑study visit at 24 hours after surgery. Participant involvement spans from the screening appointment through the 24‑hour postoperative assessment, approximately one day in total. Recruitment is planned to commence in October 2026 and conclude in October 2027.

The investigational product is sufentanil, supplied for intravenous administration as a bolus injection or continuous infusion. The protocol specifies a dose of 75 µg delivered by a concentration‑targeted continuous intravenous infusion (TCI) model during the operative period. Administration is performed intravenously, with the infusion initiated after induction of anesthesia and maintained throughout the laparoscopic cholecystectomy. No additional dosing intervals are required beyond the intra‑operative infusion.

The comparator is fentanyl, provided for intravenous bolus injection or infusion in accordance with standard clinical practice at the study institution. The assigned dose is 750 µg administered intravenously, typically as a bolus followed by supplemental dosing as needed for intra‑operative analgesia. This regimen reflects routine opioid management for urgent laparoscopic cholecystectomy.

All study drugs are prepared in identical, unlabeled syringes to preserve blinding. Dosing schedules are recorded in the case report form, and infusion rates are verified by calibrated infusion pumps. Compliance monitoring includes real‑time documentation of start and stop times, total administered volume, and periodic verification of plasma concentrations when required by the protocol. Any deviations from the prescribed regimen are reported and reviewed according to the trial’s quality‑assurance procedures.

Efficacy assessment is based on postoperative pain intensity measured with the Visual Analogue Scale (VAS) as the primary endpoint. Secondary efficacy parameters include VAS scores recorded at the first, second, and 12th postoperative hour, the occurrence of postoperative nausea or vomiting, pruritus, respiratory depression, the total micrograms of opioids administered intra‑operatively, and opioid consumption during the first 24 hours after surgery. Demographic variables (age, sex, weight, height, ASA classification) are also captured for descriptive purposes.

Pain intensity is evaluated using the validated VAS instrument at predefined time points: baseline (pre‑operative), 1 hour, 2 hours, 12 hours, and at the end of the 24‑hour postoperative period. Patient‑reported VAS scores are recorded on paper or electronic case report forms. Intra‑operative opioid dosing is extracted from the infusion pump data, and postoperative opioid use is documented from medication administration records. Collected data are analyzed to compare the sufentanil continuous‑infusion regimen with the standard fentanyl protocol, employing a non‑inferiority statistical framework for the primary VAS outcome and appropriate descriptive or inferential methods for secondary endpoints.