Ciprofol–alfentanil versus propofol–alfentanil for ureteroscopic holmium laser lithotripsy: a randomized double-blind trial

Ureteroscopic holmium laser lithotripsy (URL) demands anesthesia with stable hemodynamics, minimal injection pain, suppressed stress, and rapid recovery. Propofol-alfentanil, a common anesthesia regimen for URL, has the drawbacks of high injection pain and marked circulatory inhibition. This study compared perioperative outcomes between ciprofol-alfentanil and propofol-alfentanil for URL. This was a prospective, randomized, double-blind trial. Sixty patients aged 18–65 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing URL were randomized to the ciprofol group receiving ciprofol plus alfentanil, n = 30, or the propofol group receiving propofol plus alfentanil, n = 30. Baseline characteristics, serial systolic blood pressure (SBP) and heart rate (HR) measurements, intraoperative adverse events (hypotension, norepinephrine use), injection pain (assessed using the Numeric Rating Scale), serum norepinephrine, and recovery indicators were assessed. Statistical analysis used R 4.3.0, including t-test, Mann–Whitney U test, χ2 test, and repeated-measures analysis of variance where appropriate; P < 0.05 was considered statistically significant. The primary endpoint was the incidence of intraoperative hypotension, defined as SBP < 90 mmHg at any time during anesthesia. Secondary endpoints included serial SBP and HR measurements, norepinephrine use, injection pain, serum norepinephrine levels, and recovery indicators. Ciprofol group showed: (1) higher SBP/HR at T1-T3 (e.g., T1 SBP: 112.3 ± 8.6 vs. 98.6 ± 11.2 mmHg, P < 0.001), lower hypotension (10.0% vs. 43.3%, with a risk ratio of 0.23, 95% CI 0.07 to 0.73, and a risk difference of − 33.3 percentage points, 95% CI − 54.1 to − 12.6) and norepinephrine use (6.7% vs. 36.7%, P = 0.010); (2) lower injection pain incidence (13.3% vs. 66.7%, P < 0.001) and score (1.0 [0,2.0] vs. 4.0 [3.0,5.0], P < 0.001); (3) lower serum norepinephrine at T1/T4 (T1: 312.5 ± 38.6 vs. 405.8 ± 52.3 pg/mL, P < 0.001); (4) shorter emergence (6.2 ± 1.8 vs. 9.5 ± 2.5 min, P < 0.001) and extubation time (8.5 ± 2.3 vs. 12.8 ± 3.1 min, P < 0.001).In this single-center trial, ciprofol-alfentanil was associated with less intraoperative hypotension and injection pain, lower measured serum norepinephrine levels, and shorter emergence and extubation times than propofol-alfentanil. Larger prospectively registered trials are needed to establish comparative safety and generalizability. ChiCTR2600121646, retrospectively registered on 1 April 2026 (after completion of patient recruitment because of an administrative delay in public registry submission).Ciprofol; Alfentanil; Ureteroscopic holmium laser lithotripsy; Hemodynamic stability; Randomized controlled trial Trial registration: This clinical trial was retrospectively registered in the Chinese Clinical Trial Registry under the registration number ChiCTR2600121646 on 1 April 2026.