About this trial
Esketamine is frequently used during the perioperative period for supplemental analgesia. Small sample size trials showed that subanesthetic dose esketamine may decrease postoperative neurocognitive complications. However, conflicting results exist and optimal dose of esketamine remains to be determined. This dose-exploring pilot trial is designed to evaluate the safety and efficacy of three different perioperative esketamine dosing regimens in older patients undergoing major non-cardiac surgery. The primary purpose is to explore the optimal dosing strategy that produce maximal neurocognitive benefits with minimal adverse neuropsychiatric symptoms.
Eligibility criteria
Qualifiers
Aged >=65 but <= 90 years;
Scheduled to undergo non-cardiac surgery with an expected duration of >= 2 hours under general anesthesia;
Requiring patient-controlled intravenous analgesia (PCIA) after surgery.
Disqualifiers
Unable to communicate preoperatively due to visual or auditory impairment, language barrier, or severe dementia;
Comorbid with schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
Traumatic brain injury or neurosurgery;
Severe hepatic dysfunction (Child-Pugh Class C), severe renal dysfunction (receiving dialysis preoperatively), or American Society of Anesthesiologists physical status classification >= Ⅳ;
Trial design
Treatments tested in this trial
- Esketamine 1
- Esketamine 2
- Esketamine 3
- Normal saline
Treatment groups
Sponsors and collaborators
Peking University First Hospital
Lead sponsor
Tianjin Medical University General Hospital
Collaborator