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

Hip Fracture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458547
• Other study ID #: 4-2015-0088
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: January 21, 2019

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Desflurane
Inhalation anesthesia with desflurane at age-adjusted MAC of 0.8~1.0
• Propofol
Total intravenous anesthesia with propofol target controlled infusion
• Bupivacaine
Spinal anesthesia with 0.5% bupivacaine

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HMGB1		from preoperative baseline to 72hours
Primary	IL-6		from preoperative baseline to 72hours
Primary	NT-proBNP		from preoperative baseline to 72hours
Primary	hemoglobin		from preoperative baseline to 72hours
Primary	total lymphocyte count		from preoperative baseline to 72hours
Primary	albumin		from preoperative baseline to 72hours
Primary	creatinine		from preoperative baseline to 72hours
Primary	potassium		from preoperative baseline to 72hours
Primary	troponin-T		from preoperative baseline to 72hours
Primary	CRP		from preoperative baseline to 72hours