Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly

NCT07077265 | Completed

• 1 other identifier: MD-25-2024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to determine whether norepinephrine infusion rate (0.07 mcg/kg/min) is non-inferior to the higher dose (0.1 mcg/kg/min) in maintaining intraoperative blood pressure maintaining blood pressure of elderly patients during hip surgery

Conditions

Hypotension After Spinal Anesthesia; Elderly (People Aged 65 or More); Spinal Aneshtesia

Outcome Measures

Primary Outcomes (1)

• mean arterial pressure

  average mean arterial pressure

  0 min after spinal anesthesia till 46 min after spinal anesthesia

Secondary Outcomes (3)

• incidence of hypotension

  0 min after spinal anesthesia till 46 min after spinal anesthesia

• incidence of reactive hypertension

  0 min after spinal anesthesia till 46 min after spinal anesthesia

• incidence of bradycardia

  0 min after spinal anesthesia till 46 min after spinal anesthesia

Study Arms (2)

NE 0.1 mcg

ACTIVE COMPARATOR

norepinephrine infusion rate of 0.1 mcg/kg/min

Drug: Norepinephrine (0.1 μg/kg/min)

NE 0.07 mcg

ACTIVE COMPARATOR

norepinephrine infusion rate of 0.07 mcg/kg/min

Drug: Norepinephrine (0.07 μg/kg/min)

Interventions

Norepinephrine (0.07 μg/kg/min) DRUG

The patients will receive NE infusion at a rate 1 mL/kg/hour of 4.2 mcg/mL solution.

NE 0.07 mcg

Norepinephrine (0.1 μg/kg/min) DRUG

The patients will receive norepinephrine infusion at a rate 1 mL/kg/hour of 6 mcg/mL solution.

NE 0.1 mcg

Eligibility Criteria

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

You may qualify if:

• Elderly patients (\>65)
• ASA I-II-III
• scheduled for hip surgery under spinal anesthesia

You may not qualify if:

• Contraindication of spinal anesthesia
• history of allergy to any of the study's drugs,
• Patients with cardiac morbidities (impaired contractility with ejection fraction \< 50%, heart block, arrhythmias)
• patients with uncontrolled hypertension

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Norepinephrine

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

• Maha Mostafa, MD

  Cairo University Kasr Alainy Faculty of Medicine

  PRINCIPAL INVESTIGATOR

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: assistant professor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)