Actively Recruiting
Led by Yongtao Sun · Updated on 2023-03-29
2000
Participants Needed
1
Research Sites
4 weeks
Total Duration
This research investigates the relationship between preoperative frailty and myocardial injury after non-cardiac surgery in elderly patients. It aims to identify factors that predict myocardial injury in frail elderly patients and to explore the effects of low-dose esmolol on reducing this injury. The study focuses on elderly patients aged 65 to 90 undergoing non-cardiac surgery, addressing a critical concern about cardiac complications in this vulnerable group. Participants are randomly assigned to receive either low-dose esmolol or a placebo during surgery. The esmolol group receives a 0.5 mg/kg loading dose followed by a continuous infusion of 10 mcg/kg/min, while the control group receives an equal volume of normal saline. Both groups use patient-controlled analgesia pumps with sufentanil for postoperative pain management. The treatment continues until the end of surgery, with postoperative pain monitored and managed as needed. During the study, researchers monitor the incidence of myocardial injury within three days after surgery and record outcomes up to 30 days post-operation. Participants undergo assessments including monitoring heart rate, blood pressure, and pain levels. The trial also tracks any adverse effects and overall recovery progress. The study is designed as a double-blind, randomized controlled trial to evaluate the safety and effects of esmolol in frail elderly patients undergoing non-cardiac surgery.
CONDITIONS
Effects of Low-dose Esmolol on Myocardial Injury After Non-cardiac Surgery in Elderly Frail Patients
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery and 48 hours postoperatively
Participants receive a low-dose Esmolol infusion or placebo during non-cardiac surgery to reduce myocardial injury risk. Postoperative pain is managed with patient-controlled analgesia and additional medication if needed.
1 intraoperative treatment and 2 days of postoperative analgesia monitoring
Duration - 30 days after surgery
Participants are monitored for myocardial injury and other outcomes for up to 30 days after surgery.
Visits or assessments within 3 days post-surgery and additional assessments up to 30 days
Total: 1 location
1
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
Y
yongtao Sun, PH.D
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Yongtao Sun, Na Guo, Min Zhang...
https://pubmed.ncbi.nlm.nih.gov/38504166