Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postinduction Hypotension
• Intervention / Treatment: Drug: Normal Saline; Drug: Ephedrine

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Mostafa, MD; Phone Number: +201000365115; Email: maha.mostafa@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Alainy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; Normal Saline boluses	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
Active Comparator: ephedrine; ephedrine boluses	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postinduction hypotension	mean arterial pressure < 65 mmHg	from induction of anesthesia until 20 minutes after induction

Secondary Outcome Measures

Outcome Measure	Time Frame
area under mean arterial pressure of 65 mmHg	from induction of anesthesia until 20 minutes after induction

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2026
• First Submitted That Met QC Criteria: July 19, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: prophylaxis; ephedrine; high risk patients; major abdominal surgery; postinduction hypotension
• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Alcohols; Propanolamines; Amino Alcohols; Propanols; Phenethylamines; Ethylamines; Ephedrine; Saline Solution
• Other Study ID Numbers: MD-160-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data related to this protocol are available from principle investigator upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No