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

Hip Fractures Clinical Trial

— HypoGer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858465
• Other study ID #: KB/129/2017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2023
• Est. primary completion date: February 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly Patients
• Hip Fractures
• Lower Limb Surgery
• Spinal Anesthesia

Intervention

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

Locations

Country	Name	City	State
Poland	Infant Jesus Teaching Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	heart rate, expressed in bpm	parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.	30 min
Secondary	cardiac output, expressed in L/min	parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.	30 min
Secondary	stroke volume, expressed in ml	parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.	30 min
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	stroke volume variation, expressed in percentage (%)	parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.	30 min
Secondary	systemic oxygen delivery, expressed in ml/min	parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.	30 min
Secondary	oxygen saturation, expressed in percentage (%)	parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia.	30 min