Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension

NCT07722013 | Not Yet Recruiting

• 1 other identifier: MD-160-2026
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postinduction Hypotension

Keywords

major abdominal surgery; high risk patients; ephedrine; prophylaxis; postinduction hypotension

Outcome Measures

Primary Outcomes (1)

• incidence of postinduction hypotension

  mean arterial pressure \< 65 mmHg

  from induction of anesthesia until 20 minutes after induction

Secondary Outcomes (1)

• area under mean arterial pressure of 65 mmHg

  from induction of anesthesia until 20 minutes after induction

Study Arms (2)

control

PLACEBO COMPARATOR

Normal Saline boluses

Drug: Normal Saline

ephedrine

ACTIVE COMPARATOR

ephedrine boluses

Drug: Ephedrine

Interventions

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

control

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.

ephedrine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged \>50 years,
• weight \>50 kg,
• American Society of Anesthesiologists (ASA) Physical Status score of \> I,
• undergoing major abdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Saline Solution; Ephedrine

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Central Study Contacts

Maha Mostafa, MD

CONTACT

+201000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)