Trial reportBMC anesthesiology2026
Dynamic effects of low- and high-pressure pneumoperitoneum on optic nerve sheath diameter during laparoscopic cholecystectomy: a prospective, randomized, observer-blinded clinical trial.
Trial report in BMC anesthesiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07162922 (Impact of Intra-abdominal Pressure on Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Impact of Intra-abdominal Pressure on Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Prospective Study
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study aimed to compare the time-dependent changes in optic nerve sheath diameter (ONSD) associated with low-pressure (8 mmHg) and high-pressure (14 mmHg) pneumoperitoneum during laparoscopic cholecystectomy.
methodsIn this prospective, randomized, observer-blinded clinical trial, 76 adult patients with ASA physical status I–II were randomized into two groups receiving pneumoperitoneum at either 8 mmHg (low-pressure group) or 14 mmHg (high-pressure group). ONSD measurements were obtained using transorbital ultrasonography at five predefined time points (T0–T4). The primary outcome was the comparison of time-dependent changes in ONSD between the groups. Secondary outcomes included the incidence of postoperative nausea and vomiting and postoperative headache.
resultsAll 76 patients were included in the final analysis. Baseline demographic characteristics and perioperative variables were comparable between the groups. Generalized linear model analysis demonstrated significant effects of group, time, and group × time interaction on ONSD (all p < 0.001). ONSD increased after pneumoperitoneum induction in both groups; however, the increase was more pronounced in the high-pressure group, particularly at T1 and T2. At the second postoperative hour (T4), ONSD values in both groups approached baseline levels. The incidence of postoperative nausea, vomiting, and headache was significantly higher in the high-pressure group (nausea: p < 0.001; vomiting: p = 0.018; headache: p = 0.001).
conclusionHigh-pressure pneumoperitoneum during laparoscopic cholecystectomy was associated with greater and more pronounced transient increases in optic nerve sheath diameter. This was accompanied by a higher incidence of early postoperative nausea, vomiting, and headache in the high-pressure group.
trial registrationThe trial was registered at ClinicalTrials.gov on August 20, 2025 (NCT07162922).
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