Clinical trial NCT03858465: Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly
Official title: Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Elderly Patients
Spinal Anesthesia
Lower Limb Surgery
Keywords: Hypotension
Phenylephrine
Ephedryne
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood preasure (mean arterial pressure, systolic and diastolic blood pressure)
timeFrame: 30 min
Secondary outcomes:
measure: heart rate, expressed in bpm
timeFrame: 30 min
measure: cardiac output, expressed in L/min
timeFrame: 30 min
measure: stroke volume, expressed in ml
timeFrame: 30 min
measure: cardiac index, expressed in L/min/m2, is the ratio of cardiac output to the body surface area.
timeFrame: 30 min
measure: stroke index, expressed in ml/m2, is the ratio of stroke volume to the body surface area.
timeFrame: 30 min
measure: systemic vascular resistance, expressed in Dynes.sec.cm-⁵
timeFrame: 30 min
measure: systemic vascular resistance index, expressed in Dynes.sec.cm-⁵/m2, is the ratio of systemic vascular resistance to the body surface area.
timeFrame: 30 min
measure: stroke volume variation, expressed in percentage (%)
timeFrame: 30 min
measure: systemic oxygen delivery, expressed in ml/min
timeFrame: 30 min
measure: oxygen saturation, expressed in percentage (%)
timeFrame: 30 min
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Infant Jesus Teaching Hospital
Study officials:
affiliation: I Department of Anaesthesiology and Intensive Care, Infant Jesus Teaching Hospital
name: Rafał Kowalczyk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.