Elderly (People Aged 65 or More), Hypotension After Spinal Anesthesia, Spinal Aneshtesia
Conditions
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
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.
Interventions
The patients will receive norepinephrine infusion at a rate 1 mL/kg/hour of 6 mcg/mL solution.
DRUGNorepinephrine (0.07 μg/kg/min)
The patients will receive NE infusion at a rate 1 mL/kg/hour of 4.2 mcg/mL solution.
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean arterial pressure | 0 min after spinal anesthesia till 46 min after spinal anesthesia | average mean arterial pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of hypotension | 0 min after spinal anesthesia till 46 min after spinal anesthesia | defined as mean MAP \< 70% of the baseline or MAP\<65mmHg |
| incidence of reactive hypertension | 0 min after spinal anesthesia till 46 min after spinal anesthesia | defined as mean MAP \> 120% of the baseline |
| incidence of bradycardia | 0 min after spinal anesthesia till 46 min after spinal anesthesia | defined as heart rate \<50 bpm |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMaha Mostafa, MD
Cairo University Kasr Alainy Faculty of Medicine
Outcome results
None listed