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

NCT01837290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Renal Failure
  • Hip Fracture

Interventions

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)

DRUG

Midazolam

intravenous Midazolam 0.02 mg/kg for premedication

DRUG

saline infusion

Saline infusion to facilitate blinding

DRUG

Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg

Hyperbaric bupivacaine injection for spinal block

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Principal Investigators

  • Anis Aribogan, Prof., MD · Baskent University School of Medicine

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01837290 on ClinicalTrials.gov