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

NCT ID: NCT03858465

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2023-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

25 mg of ephedrine

participants who will receive intravenous 1,25mg/min ephedrine during 20 minutes (total dosage is 25 mg of ephedrine).

Group Type: ACTIVE_COMPARATOR

Ephedrine

Intervention Type: DRUG

intravenous 25 mg of ephedrine

0,3 mg of phenylephrine

participants who will receive intravenous 0,015mg/min phenylephrine during 20 minutes (total dosage is 0,3mg of phenylephrine).

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: DRUG

intravenous 0,3 mg of phenylephrine

Interventions

Ephedrine

intravenous 25 mg of ephedrine

Intervention Type: DRUG

Phenylephrine

intravenous 0,3 mg of phenylephrine

Intervention Type: DRUG

Other Intervention Names

Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml; Phenylephrine Unimedic 10mg/ml

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Rafal Kowalczyk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafał Kowalczyk, PhD

Role: PRINCIPAL_INVESTIGATOR

I Department of Anaesthesiology and Intensive Care, Infant Jesus Teaching Hospital

Locations

Infant Jesus Teaching Hospital

Warsaw, , Poland

Countries

Poland

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

Reference Type: BACKGROUND

PMID: 27995106 (View on PubMed)

Other Identifiers

KB/129/2017

Identifier Type: -

Identifier Source: org_study_id