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

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 Overview

• Status: Completed
• Conditions: Hip Fractures; Spinal Anesthesia; Elderly Patients; Lower Limb Surgery
• Intervention / Treatment: Drug: Ephedrine; Drug: Phenylephrine

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafał Kowalczyk, PhD; Phone Number: +48604050654; Email: mailto:raafau@op.pl
• Study Contact Backup: Name: Nadzeya Abukhouskaya; Phone Number: 533573961; Email: nadzeya.abukhouskaya@gmail.com

Study Locations

• Poland
  • Warsaw, Poland, 02-005
    • Infant Jesus Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Ephedrine; intravenous 25 mg of ephedrine; Other Names: Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml
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).	Drug: Phenylephrine; intravenous 0,3 mg of phenylephrine; Other Names: Phenylephrine Unimedic 10mg/ml

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Publications and helpful links

General Publications

• 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. doi: 10.4103/2277-9175.190943. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 24, 2019
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hypotension; Phenylephrine; Ephedryne
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Ephedrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: KB/129/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Primary and secondary outcomes will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No