Prophylactic Noradrenaline Infusion and Its Impact on Post-induction Hypotension

NCT07022730 | Completed

• 1 other identifier: noradrenaline and PIH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

researchers aim to evaluate the influence of prophylactic noradrenaline infusion on post-induction hypotension

Conditions

Post Induction Hypotension; Sepsis

Keywords

Hypotension; noradrenaline; sepsis

Outcome Measures

Primary Outcomes (1)

• Incidence of post induction hypotension in both groups

  Hypotension will be considered if MAP\< 65 mmHg

  Within the first 10 minutes of induction.

Secondary Outcomes (3)

• Incidence of acute kidney injury

  7 days post operative

• Incidence of myocardial infarction

  7 days postoperative

• Incidence of stroke

  7 days postoperative

Study Arms (2)

Noradrenaline

ACTIVE COMPARATOR

Noradrenaline will be infused at a fixed rate of 0.2 mic/kg/min at 5 minutes before induction

Drug: Noradrenaline 0.2 mcg/kg/min at 5 minutes before induction

Control

NO INTERVENTION

Patients will receive normal saline

Interventions

Noradrenaline 0.2 mcg/kg/min at 5 minutes before induction DRUG

noradrenaline will be given at a rate of 0.2 mcg/kg/min that will start 5 minutes before induction

Noradrenaline

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with sepsis undergoing source control surgery.

You may not qualify if:

• Patient refusal
• Patient with cardiac pathology ( ischemic heart disease or heart failure)
• Preoperative hemodynamic instability (defined as MAP \< 65 mmHg)
• Rapid sequence induction

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 6890, Egypt

Location

Related Publications (3)

• Goertz AW, Lindner KH, Seefelder C, Schirmer U, Beyer M, Georgieff M. Effect of phenylephrine bolus administration on global left ventricular function in patients with coronary artery disease and patients with valvular aortic stenosis. Anesthesiology. 1993 May;78(5):834-41. doi: 10.1097/00000542-199305000-00005.

  PMID: 8489054 BACKGROUND

• Czajka S, Putowski Z, Krzych LJ. Post-induction hypotension and intraoperative hypotension as potential separate risk factors for the adverse outcome: a cohort study. J Anesth. 2023 Jun;37(3):442-450. doi: 10.1007/s00540-023-03191-7. Epub 2023 Apr 21.

  PMID: 37083989 BACKGROUND

• Tangkulpanich P, Angkoontassaneeyarat C, Trainarongsakul T, Jenpanitpong C. Factors Associated with Postintubation Hypotension Among Patients with Suspected Sepsis in Emergency Department. Open Access Emerg Med. 2023 Nov 14;15:427-436. doi: 10.2147/OAEM.S426822. eCollection 2023.

  PMID: 38022743 BACKGROUND

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 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: Lecturer of anesthesia and critical care

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 15, 2025
• Study Start: June 22, 2025
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

EG (1)