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

NCT01837290 | Completed Phase 3 DMC

• 1 other identifier: KA12/166
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Renal failure,; hip fracture,; spinal anesthesia,; dexmedetomidine; patient

Outcome Measures

Primary Outcomes (1)

• Decrease at the propofol doses and postoperative early recovery

  In addition patients will be followed postoperatively first 6 hours for postoperative pain management at the ward.

  up to first 6 hours for postoperative pain management

Study Arms (2)

Group Dexmedetomidine (Group D)

ACTIVE COMPARATOR

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; Drug: Midazolam; Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg

Group Control (Group C)

PLACEBO COMPARATOR

Midazolam 0.02 mg/kg + saline infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5mg) (n=30)

Drug: Midazolam; Drug: saline infusion; Drug: Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg

Interventions

dexmedetomidine infusion for premedication DRUG

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)

Also known as: Precedex 200mcg/2ml, 121/87, Hospira İnc., Rocky Mount, NC 27801 USA

Group Dexmedetomidine (Group D)

Midazolam DRUG

intravenous Midazolam 0.02 mg/kg for premedication

Also known as: Demizolam, Dem İlaç San. ve Tic AŞ.

Group Control (Group C); Group Dexmedetomidine (Group D)

saline infusion DRUG

Saline infusion to facilitate blinding

Also known as: 0.9% sodium chloride solution

Group Control (Group C)

Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg DRUG

Hyperbaric bupivacaine injection for spinal block

Also known as: Marcaine Spinal Heavy 0.5%, Astra Zeneca, 21.01.2000-194/86

Group Control (Group C); Group Dexmedetomidine (Group D)

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baskent University: lead

Study Sites (3)

Baskent University School of Medicine Adana Research and Teaching Center

Adana, 01250, Turkey (Türkiye)

Location

Baskent University School of Medicine Adana Teaching and Research Center

Adana, 01250, Turkey (Türkiye)

Location

Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, 01250, Turkey (Türkiye)

Location

Related Publications (2)

• Ozkan-Seyhan T, Sungur MO, Senturk E, Karadeniz M, Basel A, Senturk M, Akpir K. BIS guided sedation with propofol during spinal anaesthesia: influence of anaesthetic level on sedation requirement. Br J Anaesth. 2006 May;96(5):645-9. doi: 10.1093/bja/ael055. Epub 2006 Mar 10.

  PMID: 16531442 BACKGROUND

• Ergenoglu P, Akin S, Bali C, Eker HE, Yalcin Cok O, Aribogan A. Effect of low dose dexmedetomidine premedication on propofol consumption in geriatric end stage renal disease patients. Braz J Anesthesiol. 2015 Sep-Oct;65(5):326-32. doi: 10.1016/j.bjane.2014.11.002. Epub 2015 May 2.

  PMID: 26323728 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Hip Fractures; Renal Insufficiency

Interventions

Premedication; Dexmedetomidine; Midazolam; Sodium Chloride; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Anis Aribogan, Prof., MD

  Baskent University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor, Anesthesiology and Reanimation Department

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 23, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

TU (3)