Depressive symptoms are common among perimenopausal women with breast cancer having modified radical mastectomy. Esketamine exerts antidepressant effects. This study aims to assess whether an intraoperative sub-anesthetic dose of esketamine prevents postoperative depressive symptoms in these patients. In this randomized, triple-blinded, placebo-controlled trial, we will enroll 130 perimenopausal women (aged 45-60 years) with breast cancer undergoing unilateral modified radical mastectomy. Patients will be randomly assigned with a 1:1 ratio to receive either esketamine (0.25 mg/kg i.v.) or normal saline after anesthesia induction and before skin incision. The primary outcome is the incidence of depressive symptoms at day 30 postoperatively, assessed using the Beck's Depression Inventory (BDI). Secondary outcomes include incidence of depressive symptoms and BDI scores at day 1, 3, and 180 postoperatively, anxiety symptoms and scores at day 1, 3, 30, and 180 postoperatively, pain intensity and quality of recovery at day 1 and 2 postoperatively, nausea and vomiting within 48 hours postoperatively, length of postoperative hospital stay, and cancer-specific outcomes. Data will be analyzed in the modified intention-to-treat population. This is the first trial to evaluate the effects of a sub-anesthetic dose of esketamine on depressive symptoms in perimenopausal women after modified radical mastectomy. The results of this study will help to improve their mental health and recovery after breast cancer surgery. Chinese Clinical Trial Registry (ChiCTR2200064348).

BACKGROUND: Adequate sedation is important for elderly patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Patient state index (PSI) via the SedLine® system has been utilized for real-time monitoring of anesthesia depth in surgical patients. We aimed to assess the correlation between PSI and Modified Observers Assessment of Alertness/Sedation (MOAA/S) scores in elderly patients undergoing ERCP. METHODS: This prospective cohort study included 57 elderly patients scheduled for ERCP procedures. Patients received target-controlled infusion of propofol, titrated to the sedation level of MOAA/S scores of 1 and 2. The MOAA/S scores and PSI values were recorded during sedation and recovery. We also documented procedure and recovery time, oversedation (PSI < 25 for at least 10 min and EEG burst suppression), adverse events, and fatigue scores (0-10, higher scores indicating more fatigue). RESULTS: All patients completed this study (mean age of 73 years and 63% male), with a mean procedure time of 53 min and recovery time of 37 min. Five patients (8.8%) experienced PSI < 25 for at least 10 min, and three of them (5.3%) showed EEG burst suppression. No patients developed desaturation or intra-procedural awareness. Hypotension and abdominal pain were uncommon. Nine patients (15.8%) experienced mild dizziness or nausea. The median (IQR) fatigue score was 3 (2-4) at recovery room discharge. A significant correlation was observed between the MOAA/S scores and PSI values (Spearman correlation coefficient ρ = 0.742, P < 0.001). When patients were at the MOAA/S scores of 1 and 2, the median PSI was 50 (95% CI: 48 to 52). CONCLUSION: PSI provides a useful and real-time monitoring of sedation for elderly patients undergoing ERCP. Our results showed a significant correlation between the PSI values and MOAA/S scores and suggested a PSI value of 50 with a range of 48 to 52 for maintaining adequate sedation. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2400079859).

Background

Adequate sedation is important for elderly patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Patient state index (PSI) via the SedLine® system has been utilized for real-time monitoring of anesthesia depth in surgical patients. We aimed to assess the correlation between PSI and Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores in elderly patients undergoing ERCP.

Methods

This prospective cohort study included 57 elderly patients scheduled for ERCP procedures. Patients received target-controlled infusion of propofol, titrated to the sedation level of MOAA/S scores of 1 and 2. The MOAA/S scores and PSI values were recorded during sedation and recovery. We also documented procedure and recovery time, oversedation (PSI < 25 for at least 10 min and EEG burst suppression), adverse events, and fatigue scores (0-10, higher scores indicating more fatigue).

Results

All patients completed this study (mean age of 73 years and 63% male), with a mean procedure time of 53 min and recovery time of 37 min. Five patients (8.8%) experienced PSI < 25 for at least 10 min, and three of them (5.3%) showed EEG burst suppression. No patients developed desaturation or intra-procedural awareness. Hypotension and abdominal pain were uncommon. Nine patients (15.8%) experienced mild dizziness or nausea. The median (IQR) fatigue score was 3 (2-4) at recovery room discharge. A significant correlation was observed between the MOAA/S scores and PSI values (Spearman correlation coefficient ρ = 0.742, P < 0.001). When patients were at the MOAA/S scores of 1 and 2, the median PSI was 50 (95% CI: 48 to 52).

Conclusion

PSI provides a useful and real-time monitoring of sedation for elderly patients undergoing ERCP. Our results showed a significant correlation between the PSI values and MOAA/S scores and suggested a PSI value of 50 with a range of 48 to 52 for maintaining adequate sedation.

Trial registration

Chinese Clinical Trial Registry (ChiCTR2400079859).

Postoperative complications are common after major surgical procedures, leading to increased morbidity and mortality. Regional cerebral oxygen saturation (rScO2) reflects cerebral and global perfusion, and thus it can be used to guide hemodynamic management. We aim to explore the effect of rScO2-guided blood pressure management strategy on postoperative major complications in older adults who undergo major noncardiac surgery. This randomized controlled clinical trial includes a total of 400 elderly patients receiving major noncardiac surgery and general anesthesia. Patients will be randomized (1:1) to one of two blood pressure management groups: a standard care group (targeting mean arterial pressure >65 mmHg or within 20% of baseline value), and a rScO2-guided group (absolute value of rScO2 >60% or decrease in rScO2 <10% of baseline). The primary outcome is the composite outcome of major complications (including infectious, respiratory, neurologic, cardiovascular, renal, thromboembolic gastrointestinal, and surgical complications) and deaths within the first 7 days after surgery. Secondary outcomes include the individual components of the primary outcome by day 7 after surgery and 30-day mortality. Data will be analyzed in the modified intention-to-treat population. This study will provide evidence for improving postoperative outcomes using the rScO2-guided blood pressure management among older adults who undergo major noncardiac surgery. Chinese Clinical Trial Registry (Identifier: ChiCTR2200060816).