Clinical Trials Directory

Trials / Completed

CompletedNCT03856502

Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

Impact of Intrathecal Dexamethasone Administration for Elderly Patients With Proximal Femoral Fracture

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
General Hospital Sveti Duh · Academic / Other
Sex
All
Age
50 Years – 100 Years
Healthy volunteers
Not accepted

Summary

Spinal anesthesia blocks acute pain in older patients with femur fracture. Delirium is a common complication seen after femur fracture, affecting approximately 10-16% of patients. It is associated with increased mortality at 1st year, delayed rehabilitation efforts, prolonged length of hospital stay, poorer functional outcomes, and increased risk of nursing home placement. Intrathecal dexamethasone administration improves quality of anesthesia in patients with femur fracture compared to conventional spinal anesthesia.

Detailed description

The aim of this research was to establish the influence of intrathecal dexamethasone administration in spinal anaesthesia with levobupivacaine on postoperative pain and changes of consciousness, values of cortisol levels and quality of treatment for patients with femoral fractures compared to spinal anaesthesia with only local anaesthetic. The study was planned as a prospective, observational, randomised clinical trial. A total of 60 patients ASA2 and ASA3 status, scheduled for surgical procedures were sorted into two groups and underwent surgery in spinal anesthesia with levobupivacaine with or without dexamethsone.

Conditions

Interventions

TypeNameDescription
DRUG8 mg of dexamethasoneEffect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.
DRUG12,5 mg of 0,5 % of levobupivacaineLocal anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.

Timeline

Start date
2012-11-11
Primary completion
2016-05-26
Completion
2017-07-04
First posted
2019-02-27
Last updated
2019-02-28

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT03856502. Inclusion in this directory is not an endorsement.