Effect of different targets of goal-directed fluid therapy on intraoperative hypotension and fluid infusion in robot-assisted laparoscopic gynecological surgery: a randomized non-inferiority trial

Abstract

Carotid corrected flow time (FTc) and tidal volume challenge pulse pressure variation (VtPPV) are useful clinical parameters for assessing volume status and fluid responsiveness in robot-assisted surgery, but their usefulness as goal-directed fluid therapy (GDFT) targets is unclear. We investigated whether FTc or VtPPV as targets are inferior to PPV in GDFT. This single-center, prospective, randomized, non-inferiority study included 133 women undergoing robot-assisted laparoscopic gynecological surgery in the modified head-down lithotomy position. Patients were equally divided into three groups, and the GDFT protocol was guided by FTc, VtPPV, or PPV during surgery. Primary outcomes were non-inferiority of the time-weighted average of hypotension, intraoperative fluid volume, and urine output. Secondary outcomes were optic nerve sheath diameter (ONSD) pre- and post-operatively and creatinine and blood urea nitrogen preoperatively and on day 1 post-operatively. No significant differences were observed in intraoperative hypotension index, infusion and urine volumes, and ONSD post-operatively between the FTc and VtPPV groups and the PPV group. No differences in serum creatinine and urea nitrogen levels were identified between the FTc and VtPPV groups preoperatively, but on day 1 post-operatively, the urea nitrogen level in the FTc group was higher than that in the PPV group (4.09 ± 1.28 vs. 3.0 ± 1.1 mmol/L, 1.08 [0.59, 1.58], p < 0.0001), and the difference from the preoperative value was smaller than that in the PPV group (- 2 [- 2.97, 1.43] vs. - 1.34 [- 1.9, - 0.67], p = 0.004). FTc- or VtPPV-guided protocols are not inferior to that of PPV in GDFT during robot-assisted laparoscopic surgery in the modified head-down lithotomy position.Trial registration: Chinese Clinical Trial Registry (ChiCTR2200064419).

Keywords: Carotid corrected flow time; Goal-directed fluid therapy; Hypotension; Pulse pressure variation; Robot-assisted; Tidal volume challenge.