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Not yet recruitingNCT07869693Updated Oct 9, 2026

Pre-induction Norepinephrine in Septic Patients Undergoing Surgery

An interventional study of Norepinephrine in Sepsis and Hypotension, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

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

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This randomized controlled trial aims to evaluate the effect of early pre-induction norepinephrine infusion on perioperative hemodynamic stability in septic patients with SOFA score ≥2 undergoing surgery under general anesthesia.

Read the detailed description

Induction of general anesthesia in septic patients can cause severe hypotension due to vasodilation and reduced preload. Pre-emptive norepinephrine infusion may prevent post-induction hemodynamic collapse.

This prospective double-blind randomized trial will compare continuous prophylactic norepinephrine infusion started 30 minutes before induction versus standard care with rescue vasopressors only in adult septic patients undergoing surgery.

02

Conditions studied

  • Sepsis
  • Hypotension

Keywords

  • Norepinephrine
  • Assiut
  • General anesthesia
  • Hemodynamic stability
  • SOFA score
  • Sepsis
03

In context

Sepsis

1,903 studies on the registry are indexed under Sepsis; 466 are open to participants now.

This study's planned enrollment of 90 is below the median of 105 across 899 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,919 studies on the registry; 2,116 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • - Age 18 to 65 years
  • Diagnosed with severe sepsis with SOFA score ≥2
  • Scheduled for surgery under general anesthesia
  • ASA physical status III or IV
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Severe pre-existing cardiovascular compromise
  • Known allergy or hypersensitivity to norepinephrine
  • Pregnancy or lactation
  • Refusal to participate
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Early Norepinephrine

    Continuous intravenous norepinephrine infusion at 0.07 mcg/kg/min initiated 30 minutes before induction of general anesthesia and maintained intraoperatively.

    Drug: Norepinephrine

  • Active comparator
    Control

    No prophylactic norepinephrine before induction. Vasopressors administered only as rescue medication for hypotension.

    Drug: Norepinephrine

Interventions

  • DrugNorepinephrine

    Continuous intravenous infusion of norepinephrine.

06

What researchers measure

Primary outcomes

  1. Incidence of post-induction hypotension

    Number of patients with mean arterial pressure drop greater than 20% from baseline or mean arterial pressure less than 65 mmHg within the first 30 minutes after induction of general anesthesia.

    Time frame: Periprocedurally

Secondary outcomes

  1. Mean arterial pressure

    Mean arterial pressure in mmHg.

    Time frame: Periprocedurally

  2. Total dose of rescue vasopressors

    Mean total dose of rescue vasopressors administered intraoperatively in micrograms.

    Time frame: Immediately after the intervention/procedure/surgery

  3. Total volume of intravenous fluids

    Mean total volume of intravenous fluids administered intraoperatively in milliliters.

    Time frame: Immediately after the intervention/procedure/surgery

  4. Length of ICU stay

    Mean length of intensive care unit stay in days.

    Time frame: At 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869693
Lead sponsor
Assiut University
Responsible party
Rofaida mamdouh ashry (Resident Physician, Anaesthesia , ICU and pain management department, Assiut University) — Principal investigator
First posted
Oct 9, 2026
Start date
Oct 10, 2026 (estimated)
Primary completion
Oct 10, 2027 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

Rofaida M ashry, Resident
Contact
rofaida.ashry@gmail.com
01003823614
Hamdy A Yousef, prof
study chair · Anaesthesia , ICU and pain management Department, Assiut University Hospitals

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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