NCT03858465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

23 days

First QC Date

February 20, 2019

Last Update Submit

February 23, 2023

Conditions

Hip FracturesElderly PatientsSpinal AnesthesiaLower Limb Surgery

Keywords

HypotensionPhenylephrineEphedryne

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • heart rate, expressed in bpm

    30 min

  • cardiac output, expressed in L/min

    30 min

  • stroke volume, expressed in ml

    30 min

  • cardiac index, expressed in L/min/m2, is the ratio of cardiac output to the body surface area.

    30 min

  • stroke index, expressed in ml/m2, is the ratio of stroke volume to the body surface area.

    30 min

  • +5 more secondary outcomes

Study Arms (2)

25 mg of ephedrine

ACTIVE COMPARATOR

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

Drug: Ephedrine

0,3 mg of phenylephrine

ACTIVE COMPARATOR

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

Drug: Phenylephrine

Interventions

EphedrineDRUG

intravenous 25 mg of ephedrine

Also known as: Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml
25 mg of ephedrine
PhenylephrineDRUG

intravenous 0,3 mg of phenylephrine

Also known as: Phenylephrine Unimedic 10mg/ml
0,3 mg of phenylephrine

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • elderly (age more than 65 years)
  • hip fracture scheduled for lower limb surgery under spinal anesthesia
  • spinal anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infant Jesus Teaching Hospital

Warsaw, 02-005, Poland

Location

Related 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.

    PMID: 27995106BACKGROUND

MeSH Terms

Conditions

Hip FracturesHypotension

Interventions

EphedrinePhenylephrine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylaminesEthanolamines

Study Officials

  • Rafał Kowalczyk, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 28, 2019

Study Start

February 1, 2019

Primary Completion

February 24, 2019

Study Completion

February 1, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations

PL(1)