RecruitingNot ApplicableNCT06343259

The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury

Comparison of The Effects of General Anesthesia and Spinal Anesthesia on The Development of Postoperative Myocardial Injury in Elderly Patients Undergoing Hip Surgery


Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Enrollment

100 participants

Start Date

Apr 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this prospective, randomized, single-blind study, we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery. Cardiovascular events are a leading cause of mortality and morbidity following non-cardiac surgery, with myocardial injury after non-cardiac surgery (MINS) being a significant concern. MINS, characterized by asymptomatic elevation of troponin levels without accompanying ECG findings, is closely associated with postoperative mortality. With the increasing prevalence of comorbidities in the elderly population and the rising frequency of non-cardiac surgeries in this demographic, understanding the effects of different anesthesia types on postoperative myocardial injury is crucial.


Eligibility

Min Age: 65 Years

Inclusion Criteria3

  • who will undergo hip surgery
  • ASAII-III
  • Over the age of 65

Exclusion Criteria6

  • Patients diagnosed with sepsis, pulmonary embolism, decompensated heart failure, chronic kidney failure.
  • Patients who underwent cardioversion in the last 6 months or experienced myocardial infarction.
  • Patients with a surgical history in the last month.
  • Patients who required intubation in the intensive care unit.
  • Patients with a baseline Hs-Troponin T value exceeding 20 ng/L.
  • Patients with a postoperative peak Hs-Troponin T value higher than baseline.

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Interventions

PROCEDUREGeneral Anesthesia

After preoxygenation, intravenous fentanyl (1 μg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg) will be used for anesthesia induction. Intubation will be performed with a 7.0-8.0 sized tube, followed by the initiation of mechanical ventilation (tidal volume: 6-8 ml/kg, respiratory rate: 12 breaths/min). Sevoflurane will be used to maintain anesthesia (0.7-1 MAC), and remifentanil infusion will be administered for analgesia. Postoperatively, tramadol (1 mg/kg) and paracetamol (10 mg/kg) will be administered intravenously. Neuromuscular blockade will be reversed using sugammadex. Patients with an Aldrete Recovery Score ≥9 will be transferred to the post-anesthesia care unit after extubation.

PROCEDURESpinal Anesthesia

Patients will be positioned laterally with the hip to be operated on the lower side, and skin asepsis will be ensured, followed by sterile draping. A dural puncture will be performed at the L3-4 spinal level using a 22-25 gauge Quincke-tip spinal needle. After the detection of cerebrospinal fluid, 7.5 mg of 0.5% hyperbaric bupivacaine will be slowly injected. Following a 10-minute interval, the sensory block level will be assessed using the pinprick test and modified Bromage scale, aiming for a T10 sensory block. Surgery will commence upon achieving adequate sensory block. Postoperatively, patients will be transferred to the recovery room. Patients failing to attain sufficient sensory block and experiencing pain will undergo transition to general anesthesia, terminating their cases.


Locations(1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

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NCT06343259


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