The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury

NCT06343259 | Recruiting

• 1 other identifier: 2534
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Injury After Non-cardiac Surgery; Hypotension During Surgery; Anesthesia, General; Anesthesia, Spinal

Keywords

MINS; Anesthesia, General; Anesthesia, Spinal; Hip Fractures; Myocardial Infarction; Troponin T

Outcome Measures

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.

  up to 72 hour

Secondary Outcomes (2)

• The duration of intensive care unit (ICU) stay

  up to 90 days

• The duration of hospital stay

  up to 90 days

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

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.

Procedure: General Anesthesia

Spinal Anesthesia

ACTIVE COMPARATOR

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.

Procedure: Spinal Anesthesia

Interventions

General Anesthesia PROCEDURE

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.

Also known as: propofol, fentanyl, rocuronium, sevoflorane, mechanical ventilation

General Anesthesia

Spinal Anesthesia PROCEDURE

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.

Also known as: bupivacain

Spinal Anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34396, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Myocardial Infarction

Interventions

Anesthesia, General; Propofol; Fentanyl; Rocuronium; Respiration, Artificial; Anesthesia, Spinal; Bupivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy; Anesthesia, Conduction; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Mustafa Bilgehan AYIK

CONTACT

+905377247984; drbilgehanayik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 2, 2024
• Study Start: April 5, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 18, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)