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OpenTrials
Completed

NCT Number: NCT02458547

Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients

Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. While many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. Moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. This study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with bupivacaine.

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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 65 years scheduled for elective or emergency hip fracture surgery.

Exclusion criteria

  • Patient refusal
  • Inflammation or wound at puncture site, increased intracranial pressure, bleeding diathesis
  • Allergies to propofol or its ingredients, soybeans or peanuts
  • Patients with altered mental status
  • Illiterate patients or foreigners

Treatment and study plan

Desflurane

Drug

Inhalation anesthesia with desflurane at age-adjusted MAC of 0.8~1.0

Propofol

Drug

Total intravenous anesthesia with propofol target controlled infusion

Bupivacaine

Drug

Spinal anesthesia with 0.5% bupivacaine

Primary outcomes

  1. HMGB1

    Time frame: from preoperative baseline to 72hours

  2. IL-6

    Time frame: from preoperative baseline to 72hours

  3. NT-proBNP

    Time frame: from preoperative baseline to 72hours

  4. hemoglobin

    Time frame: from preoperative baseline to 72hours

  5. total lymphocyte count

    Time frame: from preoperative baseline to 72hours

  6. albumin

    Time frame: from preoperative baseline to 72hours

  7. creatinine

    Time frame: from preoperative baseline to 72hours

  8. potassium

    Time frame: from preoperative baseline to 72hours

  9. troponin-T

    Time frame: from preoperative baseline to 72hours

  10. CRP

    Time frame: from preoperative baseline to 72hours

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2015
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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