Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly

Overview

Spinal anesthesia is often used for lower limb surgery in elderly. Hypotension is a side effect of spinal block. In this study, intravenous ephedrine and phenylephrine will be compared with each other to prevent spinal anesthesia-induced hypotension, which is defined in absolute terms as a systolic blood pressure < 100 mmHg or in relative terms as a 20% fall of systolic blood pressure from baseline.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 24, 2019

Detailed Description

Randomized single centre clinical randomized study will be performed on 50 participants. The inclusion criteria are participants (age more than 65 years) with proximal femoral fracture scheduled for lower limb surgery under spinal anesthesia. The Ethics Committee approved this prospective study. Informed consent will be taken from individual subjects. Participants are randomly allocated into one of the two study groups. Group A: participants who will receive intravenous 25 mg of ephedrine added to syringe with 50 ml 0,9% sodium chloride solution during 20 minutes. Group B: Phenylephrine 5 mg will be added to syringe with 50 ml 0,9% sodium chloride solution, participants will receive intravenous 0,3 mg of phenylephrine during 20 minutes. Randomization is achieved with the help of Random.org. In order to reduce pain prior to spinal anesthesia an ultrasound-guided fascia iliaca block will be performed using a volume of 30 ml ropivacaine 0,2%. After skin infiltration with 3 ml of lidocaine, a 25G Pencan spinal needle will be inserted at the L3-L4 or L4-L5 vertebral interspaces. After aspirating cerebrospinal fluid, participants will receive hyperbaric bupivacaine 0.5% at 0,11 mg/cm according to the participant height. Ephedrine and phenylephrine will be given intravenous immediately after injection of bupivacaine. Impedance cardiography will be used to measure hemodynamic parameters: cardiac output, stroke volume, cardiac index, stroke index, systemic vascular resistance, systemic vascular resistance index. Heart rate, blood pressure and oxygen saturation will also be controlled. All these parameters will be measured and recorded every 5 minutes until 30 minutes after spinal anesthesia. The data will be statistically analyzed.

Interventions

  • Drug: Ephedrine
    • intravenous 25 mg of ephedrine
  • Drug: Phenylephrine
    • intravenous 0,3 mg of phenylephrine

Arms, Groups and Cohorts

  • Active Comparator: 25 mg of ephedrine
    • participants who will receive intravenous 1,25mg/min ephedrine during 20 minutes (total dosage is 25 mg of ephedrine).
  • Active Comparator: 0,3 mg of phenylephrine
    • participants who will receive intravenous 0,015mg/min phenylephrine during 20 minutes (total dosage is 0,3mg of phenylephrine).

Clinical Trial Outcome Measures

Primary Measures

  • blood preasure (mean arterial pressure, systolic and diastolic blood pressure)
    • Time Frame: 30 min
    • parameter will be measured and recorded every 5 min after spinal anesthesia.

Secondary Measures

  • heart rate, expressed in bpm
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • cardiac output, expressed in L/min
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • stroke volume, expressed in ml
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • cardiac index, expressed in L/min/m2, is the ratio of cardiac output to the body surface area.
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • stroke index, expressed in ml/m2, is the ratio of stroke volume to the body surface area.
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • systemic vascular resistance, expressed in Dynes.sec.cm-⁵
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • systemic vascular resistance index, expressed in Dynes.sec.cm-⁵/m2, is the ratio of systemic vascular resistance to the body surface area.
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • stroke volume variation, expressed in percentage (%)
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • systemic oxygen delivery, expressed in ml/min
    • Time Frame: 30 min
    • parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
  • oxygen saturation, expressed in percentage (%)
    • Time Frame: 30 min
    • parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia.

Participating in This Clinical Trial

Inclusion Criteria

  • elderly (age more than 65 years) – hip fracture scheduled for lower limb surgery under spinal anesthesia – spinal anesthesia Exclusion Criteria:

  • contraindications to spinal anesthesia – participant refusal – age less than 65 – bradycardia (heart rate less than 60) – participants unable to give consent or inability to communicate

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Warsaw
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rafal Kowalczyk, Principal Investigator – Medical University of Warsaw
  • Overall Official(s)
    • Rafał Kowalczyk, PhD, Principal Investigator, I Department of Anaesthesiology and Intensive Care, Infant Jesus Teaching Hospital
  • Overall Contact(s)
    • Rafał Kowalczyk, PhD, +48604050654, mailto:raafau@op.pl

References

Abbasivash R, Sane S, Golmohammadi M, Shokuhi S, Toosi FD. Comparing prophylactic effect of phenylephrine and ephedrine on hypotension during spinal anesthesia for hip fracture surgery. Adv Biomed Res. 2016 Oct 26;5:167. eCollection 2016.

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