The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury
NCT ID: NCT06343259
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-04-05
2024-08-18
Brief Summary
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Detailed Description
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The Vascular Events in Noncardiac Surgery Patient Cohort Assessment (VISION) study, designed to evaluate major vascular events in patients undergoing non-cardiac surgery, reported a global prevalence of MINS at 8% with over a threefold increase in 30-day mortality. The diagnostic threshold for MINS as determined by the VISION study is a non-Hs troponin T level of ≥0.03 ng/mL.
With the increasing elderly population burdened with comorbidities globally, the frequency of non-cardiac surgeries in elderly patients has risen. Despite advancements in surgical and anesthetic fields, the incidence of MINS and associated mortality continue to escalate. Risk factors associated with MINS highlight age over 75 and the presence of comorbidities. Orthopedic surgeries are most commonly performed in elderly patients, with perioperative acute myocardial infarction (MI) incidence shown to increase by 31-fold in knee surgeries and 25-fold in hip surgeries. Postoperative pain and opioid use in this patient group significantly contribute to overlooked myocardial ischemia.
In a sub-study of the VISION trial examining cardiovascular outcomes of orthopedic surgery, the incidence of MINS was reported at 11.9%, with 30-day mortality rates of 1% in MINS-absent patients and 9.8% in MINS-present patients, markedly higher than non-orthopedic surgeries.
Several studies have identified perioperative and postoperative hypotension as the primary risk factor for MINS, emphasizing the importance of anesthesia management in preventing perioperative hypotension. However, no study has specifically focused on the relationship between chosen anesthesia technique and the development of hypotension and MINS. George R. and colleagues conducted a prospective observational cohort study in India analyzing the incidence and risk factors of MINS, finding a higher incidence in patients receiving peripheral nerve blocks compared to general anesthesia and spinal anesthesia, particularly in patients with high cardiac comorbidities. Nonetheless, no significant relationship was observed between the chosen anesthesia technique and the development of MINS in the orthopedic surgery subgroup of the VISION study.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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General 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.
General 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.
Spinal 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.
Spinal 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.
Interventions
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General 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.
Spinal 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASAII-III
* Over the age of 65
Exclusion Criteria
* 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.
65 Years
ALL
Yes
Sponsors
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Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Responsible Party
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Mustafa Bilgehan Ayik
principal investigator
Locations
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Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2534
Identifier Type: -
Identifier Source: org_study_id
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