Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04195321 |
| Other study ID # |
D-7-2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
March 26, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
Kasr El Aini Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Various regimens were used for prevention of hypotension; most of these regimens included the
use of vasopressors. Ephedrine is commonly used vasopressor for management and prophylaxis of
hypotension; however, ephedrine is usually associated with tachycardia which increases oxygen
consumption; thus, it might be potentially harmful in this special group of patients.
Phenylephrine (PE) is another vasopressor which is characterized by α agonistic activity. PE
had been the preferred vasopressor for prophylaxis against post-spinal hypotension especially
in obstetric population.
it was reported that PE improved the intraoperative hemodynamic profile in elderly patients
undergoing lower extremities orthopedic surgery under spinal anesthesia. PE (a pure α
agonist) was reported to decrease cardiac output which limit its use in patients with
compromised cardiac contractility; this fact makes the use of PE in elderly patients
questionable. Norepinephrine (NE) is characterized by α agonistic and weak β agonistic
activity; thus, NE is characterized by less cardiac depression compared to PE. NE was
recently introduced for prophylaxis against post-spinal hypotension in obstetric anesthesia.
In non-obstetric population, although, NE infusion effectively maintained patients
hemodynamics during general anesthesia, its use during spinal anesthesia was not adequately
evaluated in elderly population
Description:
Preoperative fasting instructions are 6 hours for solid food, and clear fluid will be allowed
up to 2 hours preoperative. Upon arrival to the operating room, routine monitors (ECG, pulse
oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be
secured, and routine pre-medications (ranitidine 50 mg and midazolam 0.02 mg/kg slow IV) will
be administrated. Baseline preoperative blood pressure will be recorded in the supine
position as average of 3 reading with difference less than 5 mmHg.
Fluid management:
Before initiation of spinal anesthesia for all study patients, Electrical cardiometry device
(ICON; Cardiotonic, Osypka; Berlin, Germany) will be applied to the patient through 4
electrodes at the following sites: Below the left ear, Above the midpoint of the left
clavicle, Left mid-axillary line at level of the xiphoid process and 5 cm inferior to the
third electrode. Stroke volume variability (SVV) will be measured while patient maintaining
standard calm breathing at a rate of 6-8 breath/minute before the intrathecal injection. The
patient with SVV more than 13% with be considered fluid responder 16 and will receive fluid
bolus of 5 ml/kg ringer acetate over 10 minutes. The fluid bolus will be repeated till SVV
less than 13%, then spinal anesthesia will be performed. After induction of spinal anesthesia
maintenance fluid as 2ml/kg/hour of ringer acetate will be commenced.
Anesthetic management:
Spinal anesthesia will be performed in the sitting position at level of second and third or
third and forth lumber interspaces with a 25-gauge spinal needle. After confirming
cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be
injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the
study with a goal of T6-8 dermatomal level block. If spinal anesthesia failed, the patient
will be excluded from the study and will be managed according to the attending anesthetist
discretion, local expertise and clinical practice.
Vasopressor management:
Vasopressor infusion will be started after obtaining CSF through the same line with IV fluids
aided by a three-way stop-cock after induction of spinal anesthesia, patients will receive
the vasopressor infusion according to the previous randomization Any episode of spinal
induced hypotension (defined as mean arterial pressure < 80% of the baseline reading 30
minutes after spinal block) will be managed by 5 mcg norepinephrine and the infusion rate
will be increased by 20%. If the hypotensive episode persisted for 2 minutes, another bolus
of norepinephrine will be administered.
If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be
manged with 0.5 mg of atropine IV. If bradycardia occurred with hypertension (MAP increase
25% over the baseline), the vasopressor infusion will be stopped.
If hypertension occurred (defined as increased mean arterial pressure by > 25% 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. If the patient developed
hypotension after stoppage of the infusion, management will depend on the fluid status of the
patient. If the cause of hypotension was blood loss, replacement will be done (3:1 of ringer
acetate till transfusion threshold met then packed RBC is given with target haemoglobin
≥9gm/dl). If the hypotension was not related to blood loss, vasopressor will be re-initiated
at the last dose before stoppage
