Effects of Dexmedetomidine Premedication on Geriatric Patients With Chronic Renal Failure Undergoing Hip Surgery

This study is currently recruiting participants.
Verified April 2013 by Baskent University
Sponsor:
Information provided by (Responsible Party):
Pinar Ergenoglu, Baskent University
ClinicalTrials.gov Identifier:
NCT01837290
First received: April 17, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

Geriatric patients (age ≥ 65 years) undergo surgery for hip fractures that develops due to osteoporosis and falls. Dialysis-dependent chronic kidney disease is associated with an increased risk of cardiovascular comorbidity. Elective or urgent surgical operations may be required for geriatric patients with end stage renal disease. These patients have severe comorbidities, fluid, electrolyte disturbances and drug metabolism abnormalities during the perioperative period. For this reasons a careful anesthesia plan should be planned and performed. Spinal anesthesia can be used for hip fracture surgery at geriatric patients with chronic renal failure. Anterograde femoral intramedullary nailing can be performed in supine position with a fracture table. Intraoperative sedation might be necessary for patients under regional anesthesia on traction table. Dexmedetomidine is an alpha 2 receptor agonist that is being used as an agent for its sedative and adjuvant analgesic effects.

The aim of this study is to evaluate the effects of dexmedetomidine premedication on geriatric patients with end stage renal disease, who will be undergoing a surgical operation for hip fracture under spinal anesthesia with hyperbaric bupivacaine and BIS (Bispectral Index) guided sedation with intraoperative propofol infusion.


Condition Intervention Phase
Chronic Renal Failure
Hip Fracture
Drug: dexmedetomidine infusion for premedication
Drug: Midazolam
Drug: saline infusion
Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery The Effect of Dexmedetomine Premedication on the Bispectral Index Values Using Sedation With Propofol During Spinal Anesthesia on Geriatric Chronic Renal Failure Patients Undergoing Hip Fracture Surgery

Resource links provided by NLM:


Further study details as provided by Baskent University:

Primary Outcome Measures:
  • Decrease at the propofol doses and postoperative early recovery [ Time Frame: up to first 6 hours for postoperative pain management ] [ Designated as safety issue: Yes ]
    In addition patients will be followed postoperatively first 6 hours for postoperative pain management at the ward.


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group Dexmedetomidine (Group D)
Midazolam 0.02 mg/kg intravenously + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication + Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30)
Drug: dexmedetomidine infusion for premedication
Group Dexmedetomidine (Group D): Midazolam 0.02 mg/kg + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30)
Other Names:
  • Precedex 200mcg/2ml
  • 121/87
  • Hospira İnc., Rocky Mount, NC 27801 USA
Drug: Midazolam
intravenous Midazolam 0.02 mg/kg for premedication
Other Names:
  • Demizolam
  • Dem İlaç San. ve Tic AŞ.
Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg
Hyperbaric bupivacaine injection for spinal block
Other Names:
  • Marcaine Spinal Heavy 0.5%
  • Astra Zeneca
  • 21.01.2000-194/86
Placebo Comparator: Group Control (Group C)
Midazolam 0.02 mg/kg + saline infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5mg) (n=30)
Drug: Midazolam
intravenous Midazolam 0.02 mg/kg for premedication
Other Names:
  • Demizolam
  • Dem İlaç San. ve Tic AŞ.
Drug: saline infusion
Saline infusion to facilitate blinding
Other Name: 0.9% sodium chloride solution
Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg
Hyperbaric bupivacaine injection for spinal block
Other Names:
  • Marcaine Spinal Heavy 0.5%
  • Astra Zeneca
  • 21.01.2000-194/86

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elderly patients (above 65 years of age)
  • end stage renal failure on dialysis treatment (Glomerular filtration rate <15, Stage 5)
  • hip fracture

Exclusion Criteria:

  • Patients with decompensated respiratory or heart failure,
  • liver failure
  • morbid obesity
  • mental disorders
  • cognitive disorders
  • language problems
  • patients with a contraindication for regional anesthesia (coagulopathy, history of anticoagulant use, spinal cord disease and patients who rejected spinal anesthesia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837290

Contacts
Contact: Pinar Ergenoglu, MD 903223272727 ext 1010 pergenoglu@yahoo.com

Locations
Turkey
Baskent University School of Medicine Adana Teaching and Research Hospital Recruiting
Adana, Turkey, 01250
Contact: Pinar Ergenoglu, MD    903223272727 ext 1010    pergenoglu@yahoo.com   
Baskent University School of Medicine Adana Research and Teaching Center Recruiting
Adana, Turkey, 01250
Contact: Anis Aribogan, Prof., MD    903223272727 ext 1341    aaribogan@yahoo.com   
Baskent University School of Medicine Adana Teaching and Research Center Recruiting
Adana, Turkey, 01250
Contact: Sule Akin, Ass.Prof.MD    903223272727 ext 1156    sakin00@yahoo.com   
Sponsors and Collaborators
Baskent University
Investigators
Study Director: Anis Aribogan, Prof., MD Baskent University School of Medicine
  More Information

Publications:
Responsible Party: Pinar Ergenoglu, Specialist Doctor, Anesthesiology and Reanimation Department, Baskent University
ClinicalTrials.gov Identifier: NCT01837290     History of Changes
Other Study ID Numbers: KA12/166
Study First Received: April 17, 2013
Last Updated: April 23, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Baskent University:
Renal failure,
hip fracture,
spinal anesthesia,
dexmedetomidine
patient

Additional relevant MeSH terms:
Kidney Failure, Chronic
Fractures, Bone
Hip Fractures
Renal Insufficiency
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Anesthetics
Bupivacaine
Midazolam
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on April 16, 2014