Cerebral hemodynamics and safety of ciprofol in laparoscopic bariatric surgery: a parallel, double-blind, randomized controlled clinical trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background Obesity has become a global health crisis. Laparoscopic bariatric surgery, a commonly used method for treating obesity, can significantly alter intracranial hemodynamics due to surgical positioning and pneumoperitoneum pressure, thereby increasing the likelihood of perioperative complications in obese individuals. Ciprofol, a novel propofol analog, offers advantages such as reduced side effects and enhanced stability, but its effects on brain blood flow regulation in obese patients are not yet fully understood. This clinical trial was designed to validate its superior efficacy in preserving cerebral perfusion and maintaining hemodynamic stability. Methods The trial was structured as a randomized, double-blind research with parallel arms. Research was carried out from 1st February 2023 to 30th May 2023 in the First Affiliated Hospital of Jinan University. Patients, with body mass index ranging from 30.6 to 51.2 kg/m 2 , scheduled for laparoscopic bariatric surgery, were randomly allocated to receive either propofol or ciprofol. For anesthesia induction and maintenance, participants in each group were administered propofol or ciprofol as the sedative agent. The mean cerebral blood flow velocities (CBFVm) were detected using transcranial doppler ultrasonography, and mean arterial pressure (MAP), heart rate and adverse events were recorded during surgery. Results A total of 43 patients were ultimately included in this study (21 in the propofol group and 22 in the ciprofol group). Compared with baseline, patients receiving propofol group exhibited marked reductions in CBFVm at T 1 , T 2 , T 3 , T 4 , T 5 , T 7 , T 8 , T 9 and MAP at T 1 , T 2 , T 3 , T 5 , T 8 ( p < 0.05), respectively. In contrast, ciprofol- administered participants demonstrated no significant change in CBFVm, and MAP only showed a significant decrease at T 1 ( p < 0.05). Although there was a certain difference in ΔCBFVm between the two groups, it was not statistically significant. Additionally, 13 patients (61.9%) in the propofol group experienced pain at the injection site, compared to only three patients (13.6%) in the ciprofol group ( p = 0.001). Both groups experienced hypotension, respiratory depression, and bradycardia, but no significant differences were observed. Conclusion This study found that, compared to propofol, ciprofol may be a better anesthetic choice for obese individuals receiving laparoscopic bariatric surgery, as it maintains CBFVm and hemodynamics more steadily, causes less injection discomfort, and demonstrates comparable safety and adverse event rates to those of propofol. Clinical Trial Registration [ https://www.chictr.org.cn/showproj.html?proj=187919 ], identifier [ChiCTR2300067801].
Source: Frontiers in Medicine
Authors: Qichen Luo, Shuqing Liang, Xiaoli Wang, Zhongyou Tian, Yalan Li
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
Awards: G3278082498, G3902358611
OpenAlex ID: W4417449224