Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal Saline, Ephedrine.
- Who it may be relevant to
- Registry conditions: Postinduction Hypotension. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension in High-risk Patients Undergoing Major Abdominal Surgery: a Randomized Double-blinded Controlled Trial: a Randomized Double-blinded Controlled Trial
Overview
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.
Detailed description
Fluid responders (≥20% rise in perfusion index on passive leg raising) will receive 500-mL Ringer's boluses (up to 1500 mL). Anesthesia will be induced with fentanyl/propofol, intubated after neuromuscular blockade, and maintained with isoflurane (1.2% end-tidal). Study drug will be given at induction and every 5 minutes for 20 minutes, withheld if MAP ≥80 mmHg or a recent vasopressor dose. Hypotension (MAP \<65 mmHg) will be treated with 0.1 mg/kg ephedrine boluses (max 9 mg single). Post-incision care follows anesthetist discretion.
Interventions
- Drug Normal Saline
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 - Drug Ephedrine
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.
Primary outcome measures
- incidence of postinduction hypotension [Time frame: from induction of anesthesia until 20 minutes after induction]
Secondary outcome measures (1)
- area under mean arterial pressure of 65 mmHg [Time frame: from induction of anesthesia until 20 minutes after induction]
Eligibility criteria
Inclusion criteria
- Adult patients aged >50 years,
- weight >50 kg,
- American Society of Anesthesiologists (ASA) Physical Status score of > I,
- undergoing major abdominal surgery
Exclusion criteria
- 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
- Renal impairment
- Patients on vasopressor infusion,
- Allergy of any of the study drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Kasr Alainy Hospital — Cairo
Identifiers
NCT: NCT07722013 · MD-160-2026