An interventional study of Midodrine Oral Tablet and Metoclopramide in Hypotension, Spinal Anesthesia and Elderly, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
Hip fracture is a common and serious healthcare problem which commonly affects elderly populations. The common route of anesthesia for hip arthroplasty is spinal anesthesia. Elderly populations are characterized by high incidence of post spinal anesthesia hypotension; furthermore, elderly patients commonly have systemic medical disorder; therefore, this population is highly vulnerable to perioperative hypotension. Moreover , intraoperative hypotension during hip surgery has been recently recognized as a major risk factor for postoperative morbidity and mortality.
Through the effect of spinal anesthesia on sympathetic system Veno-dilatation, decreased venous return, and consequently decreased cardiac output and hypotension will be induced. Vasopressors are commonly used for prophylaxis against post spinal hypotension in different patient subgroups. The commonly used drugs are alpha-adrenoreceptor agonists such as ephedrine, phenylephrine, and recently norepinephrine. All these agents are effective in maintenance of blood pressure; however, they have some disadvantages; ephedrine is commonly associated with tachycardia, phenylephrine and norepinephrine are associated with bradycardia. All the former mentioned drugs are used intravenously.
Midodrine hydrochloride is another alpha-adrenoreceptor agonist drug which is used for management of various hypotensive disorders. Midodrine is the prodrug which is metabolized to desglymidodrine which is a direct arteriolar and venous vasopressor. Midodrine is characterized by being an oral drug, with minimal central nervous system side effects, and good oral bioavailability. No studies had evaluated the efficacy of midodrine for prophylaxis against post-spinal anesthesia hypotension in elderly population.
Aim of the work:
This thesis aims to evaluate the efficacy and safety of oral 5 mg of midodrine compared to placebo in prophylaxis against post-spinal hypotension in elderly patients undergoing hip arthroplasty
Participants will be instructed to fast for 6 hours for solid light meals and 2 hours for clear fluids. The baseline blood pressure will be measured in the preparation room 90 min before spinal anaesthesia as the mean of three measurements with difference of less than 10%. The patients will receive the study drug after measurement of the baseline blood pressure reading. The patient will be monitored for blood pressure and heart rate at 15 min intervals after administration of the study drug. In the operating room, routine monitors (Electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications will be administrated.
Preoperative evaluation of volume status:
All patients will be assessed for volume status before spinal block through evaluation of the inferior vena cava (IVC) collapsibility, and patients who will show IVC collapsibility > 36% will be considered fluid responders and will receive Ringer's lactate solution, 6 mL/kg ideal body weight over 15 minutes.
IVC collapsibility will be calculated as: (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter.
Anaesthetic management:
Spinal anaesthesia will be performed in the sitting position at level of L3-4 or L4-5 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 anaesthesia failed, the patient will be excluded from the study and will be managed according to the attending anaesthetist discretion, local expertise and clinical practice. After induction of spinal anaesthesia maintenance fluid as 2ml/kg/hour of ringer acetate will be commenced.
Post spinal hypotension will be defined as mean arterial pressure \< 80% of the baseline reading 30 minutes after spinal block. Hypotension will be managed by 10 mg ephedrine. Severe hypotension will be defined as mean arterial pressure \< 70% of the baseline reading and will be managed by 15 mg ephedrine. The dose of ephedrine will be repeated if the hypotensive episode persisted 2 min after the initial bolus. Bradycardia will be defined as heart rate \< 50 bpm and will be managed with 0.5 mg of atropine IV.
Blood loss will be replaced using Ringer's lactate solution at a ratio of 3:1 until transfusion threshold is reached. Further blood loss will be replaced using packed RBCs
1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.
This study's enrollment of 58 is below the median of 80 across 686 interventional studies indexed under Hypotension.
Browse Hypotension studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Uncontrolled hypertension
oral metoclopramide 10 mg, Metoclopramide tablet was chosen as a placebo because it has the same appearance of midodrine tablet with no cardiovascular effects
Drug: Metoclopramide
oral midodrine tablet (5 mg)
Drug: Midodrine Oral Tablet
oral midodrine tablet (5 mg) 90 min before performing spinal block
oral placebo (metoclopramide 10 mg tablet). 90 min before performing spinal block
Intraoperative ephedrine consumption
mg
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Incidence of post-spinal hypotension
defined as mean arterial pressure \< 80% of the baseline reading 45 minutes after induction of spinal anesthesia and not related to blood loss
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Incidence of severe spinal induced hypotension
defined as mean arterial pressure \< 60% of the baseline reading 45 minutes after induction of spinal anesthesia and not related to blood loss
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Incidence of bradycardia
as heart rate less than 50 beats per minutes
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
heart rate
beats per minutes
Time frame: 1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure
mean arterial pressure
mmHg
Time frame: 1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure
Plan to share: No — data supporting this research will be available from the PI upon reasonable request
Ran from Oct 2022 to primary completion in Jul 2023, 8 months.
Of 237 non-industry interventional studies with no phase under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 25. This study's 8 months is below that.
Counting every sponsor, half of 248 studies reached it within 12 months; a quarter within 6 and three quarters within 25.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midodrine