Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
ID06343259

Comparison of General Anesthesia and Spinal Anesthesia on Postoperative Myocardial Injury in Elderly Hip Surgery Patients

Led by Sisli Hamidiye Etfal Training and Research Hospital · Updated on 2024-07-23

100

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how general anesthesia and spinal anesthesia affect the risk of myocardial injury after hip surgery in elderly patients. This study focuses on myocardial injury after non-cardiac surgery (MINS), a condition marked by silent increases in troponin levels without ECG changes, which is linked to higher postoperative mortality. As cardiovascular events remain the leading cause of death following non-cardiac surgeries, understanding anesthesia's role in preventing MINS is important, especially given the aging population and rising surgery rates among older adults. Participants will be randomly assigned to receive either general anesthesia or spinal anesthesia during their hip surgery. General anesthesia involves medications like fentanyl, propofol, rocuronium, sevoflurane, and remifentanil, with mechanical ventilation and postoperative pain control using tramadol and paracetamol. Spinal anesthesia includes a spinal injection of hyperbaric bupivacaine to numb the lower body, with surgery starting once sufficient sensory block is confirmed. If spinal anesthesia is inadequate, patients may switch to general anesthesia. Throughout the study, participants will be monitored for myocardial injury by measuring troponin levels before surgery and up to 72 hours afterward. Secondary outcomes include the length of intensive care unit and hospital stays up to 90 days. Patients will undergo assessments such as sensory block testing and recovery scoring, with safety and recovery carefully tracked. The study lasts through the surgical and postoperative periods, focusing on heart health and recovery in elderly hip surgery patients.

CONDITIONS

Brief Title

The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for hip surgery
  • Classified as ASA physical status II or III
  • Age over 65 years
Not Eligible

You will not qualify if you...

  • Diagnosed with sepsis, pulmonary embolism, decompensated heart failure, or chronic kidney failure
  • Had cardioversion or myocardial infarction within the last 6 months
  • Underwent surgery within the last month
  • Required intubation in the intensive care unit
  • Baseline Hs-Troponin T value over 20 ng/L
  • Postoperative peak Hs-Troponin T value higher than baseline

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants undergo hip surgery under either general anesthesia or spinal anesthesia as part of the study intervention.

1 surgical visit and immediate post-anesthesia care

Post-operative Follow-up

Duration - Up to 72 hours post-surgery

Participants are monitored for myocardial injury and recovery outcomes up to 72 hours after surgery, including postoperative pain management and cardiac assessments.

Approximately 3 post-operative visits

Follow-up

Duration - Up to 90 days post-surgery

Participants are followed for duration of intensive care unit (ICU) and hospital stay to assess recovery and any complications.

Visits as part of routine hospital and ICU care

Trial Site Locations

Total: 1 location

1

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye), 34396

Actively Recruiting

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Research Team

M

Mustafa Bilgehan AYIK

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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