The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury

July 22, 2024 updated by: Mustafa Bilgehan Ayik, Sisli Hamidiye Etfal Training and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular events constitute the leading cause of mortality and morbidity following non-cardiac surgery. Myocardial Injury after Non-cardiac Surgery (MINS) is a condition diagnosed postoperatively characterized by asymptomatic troponin elevation alone. Distinguishing it from myocardial infarction, it lacks symptoms and concurrent Electrocardiography (ECG) findings, yet it correlates closely with postoperative mortality. Detection can be facilitated through troponin monitoring from preoperative period to up to 72 hours postoperatively.

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34396
        • Recruiting
        • Sisli Hamidiye Etfal Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Other Names:
  • propofol
  • fentanyl
  • rocuronium
  • mechanical ventilation
  • sevoflorane
Active Comparator: 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.
Procedure: 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 Names:
  • bupivacain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Injury After Non-Cardiac Surgery (MINS)
Time Frame: up to 72 hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of intensive care unit (ICU) stay
Time Frame: up to 90 days
The intensive care unit (ICU) stay durations of patients who develop MINS and those who do not develop MINS will be recorded and compared.
up to 90 days
The duration of hospital stay
Time Frame: up to 90 days
The hospital stay durations of patients who develop MINS and those who do not develop MINS will be recorded and compared.
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Estimated)

August 5, 2024

Study Completion (Estimated)

August 18, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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