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Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

Primary Purpose

Femoral Fracture, Cognition Disorders, Cortisol; Hypersecretion

Status

Completed

Phase

Not Applicable

Locations

Croatia

Study Type

Interventional

Intervention

8 mg of dexamethasone

12,5 mg of 0,5 % of levobupivacaine

About this trial

This is an interventional treatment trial for Femoral Fracture focused on measuring spinal anesthesia, femoral fracture, dexamethasone

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital "Sveti Duh"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group that received dexamethasone (DLSA)

group without dexamethasone (LSA)

Arm Description

The study group of 30 patients ASA status 2 or 3 received 8 mg of dexamethasone with 12,5 mg of 0,5% of levobupivacaine intrathecally for surgical reconstruction of proximal femoral fracture. Spinal anaesthesia was performed in sitting position using middle approach in intervertebral space L2-L3 or L3-L4 with spinal needles 22-27 GA.

The control group of 30 patients ASA status 2 or 3 received 12,5 mg of 0,5% of levobupivacaine intrathecally for surgical reconstruction of proximal femoral fracture. Spinal anaesthesia was performed in sitting position using middle approach in intervertebral space L2-L3 or L3-L4 with spinal needles 22-27 GA.

Outcomes

Primary Outcome Measures

postoperative cognitive change

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.

cortisol concentrations changes

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 Outcome Measures

perioperative pain intensity: Visual Analogue Scale score

Assessed using Visual Analogue Scale score and establishing postoperative analgesic requirements

glucose concentrations changes

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

Blood loss

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

Number of Participants with pulmonary embolism

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

Number of Participants with heart failure

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

Platelets changes

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

Haemoglobin changes

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

Haematocrit changes

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

Hospitalisation

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

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

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

Full Information

NCT ID

NCT03856502

First Posted

November 2, 2018

Last Updated

February 26, 2019

Sponsor

General Hospital Sveti Duh

1. Study Identification

Unique Protocol Identification Number

NCT03856502

Brief Title

Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

November 11, 2012 (Actual)

Primary Completion Date

May 26, 2016 (Actual)

Study Completion Date

July 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

General Hospital Sveti Duh

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Fracture, Cognition Disorders, Cortisol; Hypersecretion

Keywords

spinal anesthesia, femoral fracture, dexamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group that received dexamethasone (DLSA)

Arm Type

Experimental

Arm Description

Arm Title

group without dexamethasone (LSA)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

8 mg of dexamethasone

Other Intervention Name(s)

Dexamethasone KRKA, Chirocaine Abbott

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

12,5 mg of 0,5 % of levobupivacaine

Other Intervention Name(s)

Chirocaine Abbott

Intervention Description

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

Primary Outcome Measure Information:

Title

postoperative cognitive change

Description

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

Title

cortisol concentrations changes

Description

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

Secondary Outcome Measure Information:

Title

perioperative pain intensity: Visual Analogue Scale score

Description

Assessed using Visual Analogue Scale score and establishing postoperative analgesic requirements

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

Title

glucose concentrations changes

Description

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

Title

Blood loss

Description

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

Time Frame

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

Title

Number of Participants with pulmonary embolism

Description

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

Time Frame

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

Title

Number of Participants with heart failure

Description

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

Time Frame

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

Title

Platelets changes

Description

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

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

Title

Haemoglobin changes

Description

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

Time Frame

Title

Haematocrit changes

Description

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

Time Frame

Title

Hospitalisation

Description

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

Time Frame

In the time period of up to 30 days

Title

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

Description

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Livija Šakić, MD,PhD

Organizational Affiliation

University Hospital Sveti Duh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital "Sveti Duh"

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The research has been a doctoral thesis.

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Available IPD and Supporting Information:

Available IPD/Information Type