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

March 15, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

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 Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group D
General anesthesia with desflurane
Drug: Desflurane
Inhalation anesthesia with desflurane at age-adjusted MAC of 0.8~1.0
Active Comparator: Group P
General anesthesia with propofol total intravenous anesthesia
Drug: Propofol
Total intravenous anesthesia with propofol target controlled infusion
Active Comparator: Group S
Spinal anesthesia with 0.5% bupivacaine
Drug: Bupivacaine
Spinal anesthesia with 0.5% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HMGB1
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
IL-6
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
NT-proBNP
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
hemoglobin
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
total lymphocyte count
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
albumin
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
creatinine
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
potassium
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
troponin-T
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours
CRP
Time Frame: from preoperative baseline to 72hours
from preoperative baseline to 72hours

Collaborators and Investigators

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

Sponsor

Yonsei University

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

May 1, 2015

Primary Completion (Actual)

January 21, 2019

Study Completion (Actual)

January 21, 2019

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0088

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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