CClinicalTrials.gg
RecruitingNCT07722013Updated Aug 6, 2026

Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension

An interventional study of Normal Saline and Ephedrine in Postinduction Hypotension, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postinduction Hypotension

Keywords

  • major abdominal surgery
  • high risk patients
  • ephedrine
  • prophylaxis
  • postinduction hypotension
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
124 participants (estimated)

Study arms

  • Placebo comparator
    control

    Normal Saline boluses

    Drug: Normal Saline

  • Active comparator
    ephedrine

    ephedrine boluses

    Drug: Ephedrine

Interventions

  • DrugNormal 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

  • DrugEphedrine

    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.

06

What researchers measure

Primary outcomes

  1. incidence of postinduction hypotension

    mean arterial pressure \< 65 mmHg

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

Secondary outcomes

  1. area under mean arterial pressure of 65 mmHg

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — data related to this protocol are available from principle investigator upon reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07722013
Lead sponsor
Cairo University
Responsible party
Ahmed Hasanin (Professor, Cairo University) — Principal investigator
First posted
Jul 23, 2026
Start date
Aug 4, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 6, 2026

Study contacts

Maha Mostafa, MD
Contact
maha.mostafa@cu.edu.eg
+201000365115

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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