Health TrialsbyHealthPanel

Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension

ConditionsPatients Undergoing Orthopedic Hip Surgery Under Spinal AnesthesiaOrthopedic Hip Sugery in Eldely Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-100
SponsorSohag University

About this trial

This prospective randomized double-blinded clinical trial aims to compare the efficacy and hemodynamic effects of prophylactic norepinephrine infusion versus phenylephrine infusion for prevention of spinal anesthesia-induced hypotension in elderly patients undergoing elective orthopedic hip surgery under subarachnoid block. Sixty-two patients aged 60 years or older will be randomly assigned into two equal groups to receive either norepinephrine infusion (8 µg/min) or phenylephrine infusion (100 µg/min) immediately after spinal anesthesia. The primary outcome is the mean heart rate during vasopressor infusion, while secondary outcomes include incidence of hypotension, severe hypotension, bradycardia, reactive hypertension, intraoperative fluid requirements, blood loss, transfusion requirements, and postoperative nausea and vomiting. Hemodynamic parameters will be monitored throughout surgery to evaluate the safety and effectiveness of both vasopressor strategies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 60 years or older.

ASA physical status I-III.

Scheduled for elective hip surgery under subarachnoid block.

Willing to provide written informed consent.

Disqualifiers

Patient refusal.

Contraindications to subarachnoid block.

Severe cardiac disease.

Uncontrolled hypertension.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Norepinephrine

    Drug

    norepinephrine infusion at 8 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.

  • Phenylephrine

    Drug

    phenylephrine infusion at 100 µg/min. Infusion will continue for 45 minutes after spinal anesthesia.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Norepinehrine groupExperimental treatment 1 intervention
Group B: Phenylepherine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean intaroperative heart rate (beats /minute) during vasopressor infusion measured by continous electrocardiogrammonitoring

Heart rate will be continously monitored using standar electrocardiogram monitoring. to compare the effect of norepinephrine versus phenylephrine infusion on hemodynamics.

Time frame
From the start of subarachnoid block until the end of surgery .

Secondary outcomes

1

Incidence of spinal anesthesia-induced hypotension

Defined as a decrease in mean arterial pressure (MAP) to \<80% of baseline measurd by non-invasive blood pressure monitoring .

Time frame
From the administration of spinal anesthesia until the end of the procedure.
2

Incidence of bradycardia

Defined as heart rate ≤ 50 beats/min.

Time frame
Throughout the intraoperative period
3

Mean arterial pressure (MAP) trends measured using non-invasive blood pressure monitoring

Monitoring the stability of blood pressure during vasopressor infusion

Time frame
Every 5 minutes from the start of spinal anesthesia until the end of surgery.
4

Incidence of reactive hypertension measured by non-invasive blood pressure monitoring

Defined as mean arterial pressure (MAP) \> 125% of baseline.

Time frame
From the start of vasopressor infusion until the end of surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov
Apply now