Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients
Primary Purpose
Hip Fracture
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desflurane
Propofol
Bupivacaine
Sponsored by
About this trial
This is an interventional other trial for Hip Fracture
Eligibility Criteria
Inclusion Criteria:
1. 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
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group D
Group P
Group S
Arm Description
General anesthesia with desflurane
General anesthesia with propofol total intravenous anesthesia
Spinal anesthesia with 0.5% bupivacaine
Outcomes
Primary Outcome Measures
HMGB1
IL-6
NT-proBNP
hemoglobin
total lymphocyte count
albumin
creatinine
potassium
troponin-T
CRP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02458547
Brief Title
Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group D
Arm Type
Experimental
Arm Description
General anesthesia with desflurane
Arm Title
Group P
Arm Type
Active Comparator
Arm Description
General anesthesia with propofol total intravenous anesthesia
Arm Title
Group S
Arm Type
Active Comparator
Arm Description
Spinal anesthesia with 0.5% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Inhalation anesthesia with desflurane at age-adjusted MAC of 0.8~1.0
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Total intravenous anesthesia with propofol target controlled infusion
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Spinal anesthesia with 0.5% bupivacaine
Primary Outcome Measure Information:
Title
HMGB1
Time Frame
from preoperative baseline to 72hours
Title
IL-6
Time Frame
from preoperative baseline to 72hours
Title
NT-proBNP
Time Frame
from preoperative baseline to 72hours
Title
hemoglobin
Time Frame
from preoperative baseline to 72hours
Title
total lymphocyte count
Time Frame
from preoperative baseline to 72hours
Title
albumin
Time Frame
from preoperative baseline to 72hours
Title
creatinine
Time Frame
from preoperative baseline to 72hours
Title
potassium
Time Frame
from preoperative baseline to 72hours
Title
troponin-T
Time Frame
from preoperative baseline to 72hours
Title
CRP
Time Frame
from preoperative baseline to 72hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
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Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients
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