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

NCT ID: NCT01837290

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-01-31

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.

Detailed Description

Patients will be randomized into two separate groups.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) Group Control (Group C): Midazolam 0.02 mg/kg + saline infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5mg) (n=30)

In this randomized double-blinded study, drugs will be prepared by an anesthesia technician who is not part of the study. The patients will be monitored with a pulse-oxymeter, 5-channel ECG, noninvasive blood pressure and BIS at the preoperative preparation room. BIS monitoring electrodes will be placed on the forehead of the patient. Study drugs will be administered to the patient by another anesthesiologist who is also not taking part in the study at the preparation room preoperatively. Dexmedetomidine (0.5 μg/kg) in 20 ml saline will be administered in 10 minutes, with an infusion pump. An equivalent volume of saline solution will be given to the control group with same method. Baseline, 1., 3., 5., 10., minute BIS SpO2, systolic, diastolic and mean arteriel pressure values will be recorded. At this period 500 ml of 0.9% NaCl will be infused. The patient will then be transported to the operating room with the supervision of this anesthesiologist. The intraoperative and postoperative follow-up of the patients will be performed by another anesthesiologist who has been blinded to the study drugs as well as the group distribution. Routine anesthesia monitoring will be performed with pulse-oxymeter, 5-lead ECG, noninvasive blood pressure measurement, pulse oxymetry and BIS. Before induction of the spinal block basal systolic, diastolic and mean blood pressures, heart rate, peripheral oxygen saturation and BIS values will be recorded. Lumbar puncture will be performed in lateral decubitis position with a Quincke 27 gauge spinal needle at the L3-L4 interspaces using the midline approach. Patients will be promptly rotated supine position after block induction. Induction of the spinal block will be accepted as 0 for all intraoperative data recordings. Systolic, diastolic and mean blood pressures, heart rate, peripheral oxygen saturation and BIS values will be recorded at 1.,3. 5. minutes and every 5 minutes for the first hour and following that every 15 minutes during surgery.

Hypotension will be described as a drop off in systolic pressure by greater then 25% from the baseline or in case systolic blood pressure decreases below 90 mm Hg, 5 mg ephedrine will be administered intravenously and the rate of crystalloid infusion will be increased.

The sensorial block level and the motor block level will be tested with the pinprick test and Bromage scale (Bromage Scale; 0: No motor block: full flexion of knee and foot, 1: Inability to raise extended leg. Just able to move knee, 2: Inability to flex knee. Able to move foot only, 3: Inability to flex ankle joint. Unable to move foot or knee), respectively. Propofol infusion will be started in all patients at a dose of 50 mcg/kg/min after the level of block arises to T10 dermatome level. Target BIS values will be between 70 and 80. Infusion rate will be titrate to provide the targeted BIS levels.The time when BIS < 80 will be recorded. In case BIS<70, propofol infusion rate will be reduced. ''Observer's assessment of alertness/sedation (OAA/S)'' scale (OAAS score 5-awake and responds readily to name spoken in normal tone, OAAS score 4-lethargic responses to name in normal tone, OAAS score 3-responds only after name is called loudly and/or repeatedly, OAAS score 2-responds only after name called loudly and mild shaking, OAAS score 1-does not respond when name is called loudly and mild shaking or prodding, OAAS score 0-does not respond to noxious stimulation) will be used for evaluating the level of sedation, with a target of OAA/S ≤ 5. OAA/S scores will be registered at the same time points. Propofol infusion will be ended at the beginning of skin suturing, and BIS>90 time will be recorded.

Patients will be monitored at the postoperative care unit and all monitoring parameters (MAP, SAP, DAP, BIS, OASS) will be registered at every 5 minutes for one hour. Criteria for transferring the ward are BIS>90, OAA/S=5, Bromage=0-1 Duration of the surgery, the amount of bleeding, vasoactive drug need, the time necessary to reach the targeted level of sedation (BIS≤80), the amount of propofol infusion, propofol dose required for targeted BIS levels and the total propofol consumption recovery time (BIS>90) first analgesic requirement time (VAS: Visual Analogue Scale;0=no pain, 10=worst pain possible,VAS≥3) and the complications will be recorded. Side effects and possible complications during the intraoperative period and the postoperative follow-up include: hypotension (SBP<90 mmHg), bradycardia (CR < 60/min), hypoxia (SpO2≤ 94 %), nausea, vomiting, and respiratory depression will be recorded and the necessary medical interventions will be administered.

Conditions

Chronic Renal Failure; Hip Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

dexmedetomidine infusion for premedication

Intervention Type: 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)

Midazolam

Intervention Type: DRUG

intravenous Midazolam 0.02 mg/kg for premedication

Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg

Intervention Type: DRUG

Hyperbaric bupivacaine injection for spinal block

Group Control (Group C)

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

Group Type: PLACEBO_COMPARATOR

Midazolam

Intervention Type: DRUG

intravenous Midazolam 0.02 mg/kg for premedication

saline infusion

Intervention Type: DRUG

Saline infusion to facilitate blinding

Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg

Intervention Type: DRUG

Hyperbaric bupivacaine injection for spinal block

Interventions

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)

Intervention Type: DRUG

Midazolam

intravenous Midazolam 0.02 mg/kg for premedication

Intervention Type: DRUG

saline infusion

Saline infusion to facilitate blinding

Intervention Type: DRUG

Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg

Hyperbaric bupivacaine injection for spinal block

Intervention Type: DRUG

Other Intervention Names

Precedex 200mcg/2ml; 121/87; Hospira İnc., Rocky Mount, NC 27801 USA; Demizolam; Dem İlaç San. ve Tic AŞ.; 0.9% sodium chloride solution; Marcaine Spinal Heavy 0.5%; Astra Zeneca; 21.01.2000-194/86

Eligibility 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)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Pinar Ergenoglu

Specialist Doctor, Anesthesiology and Reanimation Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anis Aribogan, Prof., MD

Role: STUDY_DIRECTOR

Baskent University School of Medicine

Locations

Baskent University School of Medicine Adana Research and Teaching Center

Adana, , Turkey (Türkiye)

Baskent University School of Medicine Adana Teaching and Research Center

Adana, , Turkey (Türkiye)

Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 16531442 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26323728 (View on PubMed)

Other Identifiers

KA12/166

Identifier Type: -

Identifier Source: org_study_id