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
| Type | Name | Description |
|---|---|---|
| DRUG | 8 mg of dexamethasone | Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture. |
| DRUG | 12,5 mg of 0,5 % of levobupivacaine | Local 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.