Skip to main content
OpenTrials
Completed

NCT Number: NCT07077265

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy Hospital

Cairo, 11562, Egypt

About this study

Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg in the mean arterial pressure.

Inferior vena cava collapsibility will be used to assess the patient's intravascular volume status.

After induction of spinal anesthesia, patients will receive the vasopressor infusion according to the previous randomization All drug preparations will be done by a research assistant who will be responsible for opening the envelope and group assignment with no further involvement in the study.

Any episode of hypotension (defined as mean arterial pressure (MAP) < 70% of the baseline or MAP<65mmHg) will be managed by 5 mcg norepinephrine.

If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be manged with 9 mg ephedrine. If bradycardia occurred with hypertension (MAP increase 20% over the baseline) and persisted for more than one reading, the vasopressor infusion will be stopped.

If hypertension occurred (defined as increased mean arterial pressure by > 20% of the baseline reading), vasopressor infusion will be decreased by 50%. If hypertension persisted 2 minutes after reduction of the infusion, the vasopressor infusion will be stopped. The vasopressor will be returned to 50% of the starting dose if there was further decline in blood pressure.

The infusion will continue for 45 minutes after spinal anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. mean arterial pressure

    Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia

    average mean arterial pressure

Secondary outcomes

  1. incidence of hypotension

    Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia

    defined as mean MAP < 70% of the baseline or MAP<65mmHg

  2. incidence of reactive hypertension

    Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia

    defined as mean MAP > 120% of the baseline

  3. incidence of bradycardia

    Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia

    defined as heart rate <50 bpm

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly Patients Undergoing Hip Surgery: A Randomized Controlled Non-inferiority Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.