None listed
Conditions
Brief summary
Postoperative neurocognitive disorder (pNCD) is a common and clinically significant complication in elderly patients, characterized by deterioration of cognitive functions such as memory, attention, executive function, and information processing speed, which may persist for weeks or months after surgery. Its occurrence is associated with prolonged recovery, reduced functional independence, poorer quality of life, and increased morbidity and mortality, making it an important clinical and public health issue. The development of pNCD is multifactorial and influenced by patient-related factors, surgical stress, anesthesia, and postoperative course, with mechanisms including cerebral hypoperfusion, oxidative stress, metabolic imbalance, and neuroinflammation. Different anesthetic techniques and agents appear to have varying effects on postoperative cognitive outcomes, with some evidence suggesting a higher incidence of pNCD after inhalational anesthesia such as sevoflurane compared with intravenous agents. Remimazolam, a newer ultra–short-acting benzodiazepine anesthetic with favorable pharmacokinetic and hemodynamic properties, represents a promising alternative for elderly patients, but data on its impact on postoperative neurocognitive outcomes remain limited and require further investigation.
Interventions
General Anesthesia Protocol:
Group R (Remimazolam Group):
Anesthesia induction will be performed using a balanced technique with intravenous remimazolam at a dose of 0.25 mg/kg body weight for induction, the opioid sufentanil at a dose of 0.1–0.3 µg/kg body weight, and the neuromuscular relaxant rocuronium at a dose of 0.6 mg/kg body weight. Following induction, anesthesia will be maintained with a continuous intravenous infusion of remimazolam at a rate ranging from 1–2 mg/kg/h, titrated to m
General Anesthesia Protocol: Group R (Remimazolam Group): Anesthesia induction will be performed using a balanced technique with intravenous remimazolam at a dose of 0.25 mg/kg body weight for induction, the opioid sufentanil at a dose of 0.1–0.3 µg/kg body weight, and the neuromuscular relaxant rocuronium at a dose of 0.6 mg/kg body weight. Following induction, anesthesia will be maintained with a continuous intravenous infusion of remimazolam at a rate ranging from 1–2 mg/kg/h, titrated to maintain a bispectral index (BIS) between 40 and 60, with additional sufentanil and rocuronium administered at the discretion of the anesthesiologist. Adherence to the intervention will be monitored using the anaesthetic chart, which documents all relevant perioperative and anaesthetic parameters. The investigator responsible for conducting cognitive assessments will not have access to the anaesthetic chart and will remain blinded to the intervention details.
Sponsors
University hospital centre Sestre Milosrdnice
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age; 65 years and older Undergoing elective surgery
Exclusion criteria
refusal to participate or inability to provide informed consent; pre-existing cognitive impairment; history of psychiatric illness; chronic use of psychoactive medications; contraindication to any study medication; severe hepatic impairment (Child–Pugh class C); severe renal impairment (Chronic Kidney Disease (CKD) stages 4 and 5); emergency surgical procedures; inability to undergo follow-up and cognitive testing (e.g., severe hearing impairment, significant language barrier).
Outcome results
None listed