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NCT Number: NCT07722013

Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension

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.

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Key information

Conditions

Postinduction Hypotension

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy Hospital

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. incidence of postinduction hypotension

    Time frame: from induction of anesthesia until 20 minutes after induction

    mean arterial pressure < 65 mmHg

Secondary outcomes

  1. area under mean arterial pressure of 65 mmHg

    Time frame: from induction of anesthesia until 20 minutes after induction

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Mostafa, MD

CONTACT

[email protected]

+201000365115

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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