The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSisli Hamidiye Etfal Training and Research Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

who will undergo hip surgery

ASAII-III

Over the age of 65

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • General Anesthesia

    Procedure/Surgery

    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.

  • Spinal Anesthesia

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: General AnesthesiaActive comparator 1 intervention
Group B: Spinal AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Myocardial Injury After Non-Cardiac Surgery (MINS)

Blood samples for hs-Troponin T values were obtained at 0 hours in the recovery room, followed by assessments at 6, 12, 24, 48, and 72 hours either in the ward or in the intensive care unit.The baseline values were within the normal range, with postoperative hsTnT measurements ranging between 20 and 65 ng/L, and those with at least a 5 ng/L absolute change or hsTnT levels of 65 ng/L and above were considered as MINS.

Time frame
up to 72 hour

Secondary outcomes

1

The duration of intensive care unit (ICU) stay

The intensive care unit (ICU) stay durations of patients who develop MINS and those who do not develop MINS will be recorded and compared.

Time frame
up to 90 days
2

The duration of hospital stay

The hospital stay durations of patients who develop MINS and those who do not develop MINS will be recorded and compared.

Time frame
up to 90 days

Other outcomes

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