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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NE 0.1 mcg | Active Comparator | norepinephrine infusion rate of 0.1 mcg/kg/min |
|
| NE 0.07 mcg | Active Comparator | norepinephrine infusion rate of 0.07 mcg/kg/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean arterial pressure | average mean arterial pressure | 0 min after spinal anesthesia till 46 min after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of hypotension | defined as mean MAP < 70% of the baseline or MAP<65mmHg | 0 min after spinal anesthesia till 46 min after spinal anesthesia |
| incidence of reactive hypertension | defined as mean MAP > 120% of the baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maha Mostafa, MD | Cairo University Kasr Alainy Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy Hospital | Cairo | 11562 | Egypt |
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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| 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. |
|
| 0 min after spinal anesthesia till 46 min after spinal anesthesia |
| incidence of bradycardia | defined as heart rate <50 bpm | 0 min after spinal anesthesia till 46 min after spinal anesthesia |
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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