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Completed

NCT Number: NCT03856502

Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

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.

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Key information

Conditions

Femoral Fracture Cognition Disorders Cortisol; Hypersecretion Femoral Fractures Fractures, Bone Leg Injuries Mental Disorders Neurocognitive Disorders Wounds and Injuries

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital "Sveti Duh"

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cooperative ASA 2 and ASA 3 status patients with proximal femoral fractures of one leg
  • agreed to be enrolled in the study (Informed Consent signed)

Exclusion criteria

  • patients refused to be enrolled in the study
  • patients with pre-existing cognitive disturbances before surgery
  • conditions or diseases with corticosteroid therapy, long term corticosteroid, diabetes mellitus, neurological conditions or tumors, neuroendocrine disorders or tumors
  • breaking the study protocols
  • patients who no longer wanted to be enrolled in the study
  • unexpected events when the study already started

Treatment and study plan

8 mg of dexamethasone

Drug

Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.

Other names: Dexamethasone KRKA, Chirocaine Abbott

12,5 mg of 0,5 % of levobupivacaine

Drug

Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.

Other names: Chirocaine Abbott

Primary outcomes

  1. postoperative cognitive change

    Time frame: Confusion Assessment Method scoring was assessed in 4 measure points: 1. one hour after surgery, 2. on the 3rd postoperative day at 9 am, 3. on the 5th postoperative day at 9 am, 4. on the 10th postoperative day at 9 am

    Assessed using a simplified Confusion Assessment Method scoring scale, a clinical instrument for delirium assessment used by non-psychiatric medical staff after surgery for excluding delirium. Delirium is defined in terms of 4 possible diagnostic criteria (1. acute onset or fluctuating course; 2- inattention; 3- disorganised thinking; 4- altered level of consciousness (may be defined as alert, lethargic, stupor or coma cognitive state)) and is defined as present when 1 plus 2 and either 3 or 4 diagnostic criteria are positive.

  2. cortisol concentrations changes

    Time frame: Measured in 5 measure points: 1. one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am

    Determined from patient's blood plasma assessed by Roche Elecsys Immunoassay System and defined from the laboratory reference points (185-624)nmol/L equal for each measure point; for single measuring 0,5 ml of patient's blood was taken

Secondary outcomes

  1. perioperative pain intensity: Visual Analogue Scale score

    Time frame: Visual Analogue Scale scoring (scores: 0-10) was assessed in 5 measure points every 3 hours when patient was awake: 1. 1 h before surgery, 2. 1 h after surgery, 3. on the 3rd postoperative day, 4. on the 5th postoperative day, 5. 10th postoperative day

    Assessed using Visual Analogue Scale score and establishing postoperative analgesic requirements

  2. glucose concentrations changes

    Time frame: Measured in 5 measure points (units: mmol/L): 1. one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am

    Determined form patient's blood plasma assessed by Beckman Coulter AU400 and AU680 orbOlympus Glucose Analyzer 2 devices defined from the laboratory reference points (4,4-6,4)mmol/L equal for each measure point; for single measuring 0,2 ml of patient's blood was taken

  3. Blood loss

    Time frame: During the surgical repairment and up to the removal of drainage systems (2nd postoperative day)

    Determinated by intraoperative blood loss in mililitres, amount of blood in drainage systems in mililitres, transfusion of homologous blood in mililitres

  4. Number of Participants with pulmonary embolism

    Time frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days

    Established by noted pulmonary embolism in the operating room or at the traumatology ward by the ward staff

  5. Number of Participants with heart failure

    Time frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days

    Established by noted heart failure in the operating room or at the traumatology ward by the ward staff

  6. Platelets changes

    Time frame: Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am

    Determined from laboratory values of platelets data in reference points (158-424)10^9/L equal for each measure point

  7. Haemoglobin changes

    Time frame: Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am

    Determined from laboratory values of haemoglobin data measured reference points (119-157)g/L equal for each measure point

  8. Haematocrit changes

    Time frame: Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am

    Determined from laboratory values of haematocrit data in reference points (0,356-0,470)L/L equal for each measure point

  9. Hospitalisation

    Time frame: In the time period of up to 30 days

    Calculated by number of days preoperatively from the day of admission to the day of surgical treatment and postoperatively from the day of surgical treatment to the day of hospital discharge

  10. Number of Participants who underwent surgical procedure during first 48 hours from admission

    Time frame: Calculated in hours after the patient's admission to the hospital's Emergency Department to the point of surgical reconstruction in the time period up to 48 hours

    It was defined if surgical procedure was performed in first 48 hours from admission to the hospital's Emergency Department or later reflecting morbidity and/or mortality

Sponsors and collaborators

Lead sponsor

General Hospital Sveti Duh

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Feb 27, 2019
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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