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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pinar Ergenoglu, Baskent University
ClinicalTrials.gov Identifier:
NCT01837290
First received: April 17, 2013
Last updated: January 26, 2015
Last verified: January 2015
  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.


Enrollment: 60
Study Start Date: December 2012
Study Completion Date: January 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837290

Locations
Turkey
Baskent University School of Medicine Adana Research and Teaching Center
Adana, Turkey, 01250
Baskent University School of Medicine Adana Teaching and Research Center
Adana, Turkey, 01250
Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, Turkey, 01250
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: January 26, 2015
Health Authority: Turkey: Ethics Committee

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

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Kidney Failure, Chronic
Renal Insufficiency
Femoral Fractures
Hip Injuries
Kidney Diseases
Leg Injuries
Renal Insufficiency, Chronic
Urologic Diseases
Wounds and Injuries
Bupivacaine
Dexmedetomidine
Midazolam
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators

ClinicalTrials.gov processed this record on July 01, 2015