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NCT Number: NCT03858465

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infant Jesus Teaching Hospital

Warsaw, 02-005, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine

Drug

intravenous 25 mg of ephedrine

Other names: Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml

Phenylephrine

Drug

intravenous 0,3 mg of phenylephrine

Other names: Phenylephrine Unimedic 10mg/ml

Primary outcomes

  1. 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 outcomes

  1. heart rate, expressed in bpm

    Time frame: 30 min

    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  2. 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.

  3. stroke volume, expressed in ml

    Time frame: 30 min

    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. oxygen saturation, expressed in percentage (%)

    Time frame: 30 min

    parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: HypoGer

Important dates

Study start
2019
Primary completion
2019
Study completion
2023
First posted
Feb 28, 2019
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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