Impact of anesthesia methods on adverse cardiovascular events during painless gastroscopy in frail older patients: study protocol for a prospective controlled trial

Background Frailty is common in older adults and is associated with increased perioperative cardiovascular risk. A growing number of frail elderly patients undergo painless gastroscopy, yet the optimal anesthetic strategy for this high-risk group remains unclear. Both sedation and general anesthesia may attenuate procedural stress but can themselves provoke hemodynamic instability. Robust prospective data comparing the cardiovascular safety of these two approaches in frail older patients are lacking. Method This is a single-center, prospective, randomized, controlled, single-blind trial. A total of 226 frail elderly patients (age ≥65 years, FRAIL score ≥3, ASA II-III) scheduled for elective painless gastroscopy will be randomly assigned (1:1) to midazolam-based or propofol-based procedural sedation anesthesia care. Standardized anesthetic protocols and monitoring will be used in both groups. The primary outcome is the incidence of peri-procedural cardiovascular adverse events from the start of endoscopy to discharge from the post-anesthesia care unit (PACU). Secondary outcomes include the incidence of non-cardiovascular adverse events, the incidence of delayed adverse events, postoperative pain intensity, satisfaction levels, the number of intra-procedural supplemental drug doses, the time to recovery of consciousness, and the time to recovery of airway and motor function. Discussion This trial aims to provide prospective evidence on the comparative cardiovascular safety of midazolam-based versus propofol-based procedural sedation anesthesia in frail elderly patients undergoing gastroscopy and may help guide individualized, risk-based anesthetic decision-making in this vulnerable population. Clinical trial registration ClinicalTrials.gov , identifier NCT06192082