Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension

ConditionPostinduction Hypotension

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorCairo University

About this trial

The aim of this work is to assess the efficacy of intermittent ephedrine boluses in prophylaxis against postinduction hypotension in high-risk patients undergoing major abdominal surgery, compared to standard care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged >50 years,

weight >50 kg,

American Society of Anesthesiologists (ASA) Physical Status score of > I,

undergoing major abdominal surgery

Disqualifiers

Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, significant uncontrolled arrhythmias, tight stenotic valvular lesions)

Acute cardiovascular pathologies: acute/decompensated heart failure, acute coronary syndrome

Uncontrolled hypertension (systolic blood pressure>150 mmHg)

Preoperative HR more than 110 bpm despite proper fluid management and patients with renal impairment

Trial design

Design model

Parallel

Treatments tested in this trial

Normal Saline
Drug
four 10-mL syringes of normal saline, The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose
Ephedrine
Drug
four 10-mL syringes of ephedrine 1 mg/mL. The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose.

Treatment groups

124 Participants

are divided into 2 treatment groups

Group A: controlPlacebo comparator 1 intervention

Group B: ephedrineActive comparator 1 intervention

Trial outcomes

Primary outcomes

incidence of postinduction hypotension

mean arterial pressure \< 65 mmHg

Time frame

from induction of anesthesia until 20 minutes after induction

Secondary outcomes

area under mean arterial pressure of 65 mmHg

Time frame

from induction of anesthesia until 20 minutes after induction

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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