Pre-induction Norepinephrine in Septic Patients Undergoing Surgery

NCT07869693 | Not Yet Recruiting

• 1 other identifier: NE-Sepsis-Assiut-2026
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sepsis; Hypotension

Keywords

Norepinephrine; Assiut; General anesthesia; Hemodynamic stability; SOFA score; Sepsis

Outcome Measures

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.

  Periprocedurally

Secondary Outcomes (4)

• Mean arterial pressure

  Periprocedurally

• Total dose of rescue vasopressors

  Immediately after the intervention/procedure/surgery

• Total volume of intravenous fluids

  Immediately after the intervention/procedure/surgery

• Length of ICU stay

  At 28 days

Study Arms (2)

Early Norepinephrine

EXPERIMENTAL

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

Drug: Norepinephrine

Control

ACTIVE COMPARATOR

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

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

Continuous intravenous infusion of norepinephrine.

Control; Early Norepinephrine

Eligibility Criteria

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

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Sepsis; Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hamdy A Yousef, prof

  Anaesthesia , ICU and pain management Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Rofaida M ashry, Resident

CONTACT

01003823614; rofaida.ashry@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Anaesthesia , ICU and pain management department

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 9, 2026
• Study Start: October 10, 2026
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share