NCT07077265

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Norepinephrine (0.1 μg/kg/min)	The patients will receive norepinephrine infusion at a rate 1 mL/kg/hour of 6 mcg/mL solution.
DRUG	Norepinephrine (0.07 μg/kg/min)	The patients will receive NE infusion at a rate 1 mL/kg/hour of 4.2 mcg/mL solution.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-07-22
• Last updated: 2026-03-24

Locations

1 site across 1 country: Egypt