Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients
1 other identifier
interventional
186
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2019
CompletedMarch 19, 2019
March 1, 2019
3.7 years
May 26, 2015
March 15, 2019
Conditions
Outcome Measures
Primary Outcomes (10)
HMGB1
from preoperative baseline to 72hours
IL-6
from preoperative baseline to 72hours
NT-proBNP
from preoperative baseline to 72hours
hemoglobin
from preoperative baseline to 72hours
total lymphocyte count
from preoperative baseline to 72hours
albumin
from preoperative baseline to 72hours
creatinine
from preoperative baseline to 72hours
potassium
from preoperative baseline to 72hours
troponin-T
from preoperative baseline to 72hours
CRP
from preoperative baseline to 72hours
Study Arms (3)
Group D
EXPERIMENTALGeneral anesthesia with desflurane
Group P
ACTIVE COMPARATORGeneral anesthesia with propofol total intravenous anesthesia
Group S
ACTIVE COMPARATORSpinal anesthesia with 0.5% bupivacaine
Interventions
Eligibility Criteria
You may qualify if:
- \. Patients older than 65 years scheduled for elective or emergency hip fracture surgery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 1, 2015
Study Start
May 1, 2015
Primary Completion
January 21, 2019
Study Completion
January 21, 2019
Last Updated
March 19, 2019
Record last verified: 2019-03