Comparison of Patient State Index and Bispectral Index Guidance for Remimazolam Tosylate-Based General Anesthesia in Laparoscopic Total Hysterectomy: a Prospective Randomized Controlled Trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: PSI group:The experimental group received anesthesia depth monitoring guided by the Patient State Inde X(PSI), with PSI maintained within the range of 25 to 50. When the PSI exceeded 50, the infusion rate of remimazolam was increased or a small bolus dose was administered intravenously. Conversely, when the PSI fell below 25 or signs of excessive sedation were observed, the infusion rate was reduced. Remifentanil dosage was titrated based on hemodynamic responses, such as fluctuations in heart rate or mean arterial pressure exceeding ±20% of baseline values.;BIS group:In the control group, anesthesia depth was regulated under the guidance of BIS (Bispectral Index) monitoring, with the target BIS range maintained between 40 and 60. When the BIS value exceeded 60, the infusion rate of remimazolam was increased or a small supplemental bolus was administered intravenously. Conversely, when the BIS value fell below 40 or signs of excessive sedation were observed, the infusion rate was reduced. The administration of remifentanil was adjusted—either increased or decreased—based on hemodynamic responses, such as fluctuations in heart rate or mean arterial pressure exceeding ±20% of the baseline value.; CONDITION: Depth of anesthesia and sedation during surgery PRIMARY OUTCOME: The dosage of remimazolam per unit time (mg/kg/h); SECONDARY OUTCOME: Electroencephalographic indicators: Bispectral inde X(BIS), power spectral inde X(PSI), and 95% spectral edge frequency (SEF95) values at different time points;Hemodynamic indicators: systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate at different time points;;Postoperative recovery indicators: patient's awakening time, extubation time, and PACU stay time.;Drug usage: Postoperative dosage of flumazenil.;Postoperative cognitive function: Results of short‐term postoperative cognitive assessment; INCLUSION CRITERIA: 1. Aged 20 to 60 years, American Society of Anesthesiologists (ASA) physical status classification ?‐?, with body mass inde X(BMI) ranging from 18 kg/m² to 30 kg/m²; 2. Patients scheduled for elective total hysterectomy under general anesthesia; 3. Patients capable of comprehending rating content, completing questionnaires and complying with the study protocol; 4. Patients who voluntarily sign the informed consent form.
Epistemonikos ID: 54a549d7d45586b759e1026d88ba3d68a28a0ba0
First added on: Oct 08, 2026