Midodrine for Improving Hemodynamics After Spinal Anesthesia

NCT04396548 | Completed

• 1 other identifier: Midodrine and SA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient. Prevention of this spinal anaesthesia induced hypotension is of utmost importance. Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as leg bindings and compression stockings. Midodrine is a direct acting α1-adrenoceptor agonist which causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature. The aim of this study is to evaluate the efficacy and safety of prophylactic midodrine use with preoperative fluid hydration before spinal anesthesia in the prevention of hypotension in patients undergoing elective orthopedic surgery. We hypothesize that intraoperative hypotension would be less in patients given midodrine and intravenous fluid prehydration preoperatively before spinal anesthesia.

Conditions

Hypotension After Spinal Anesthesia

Keywords

midodrine before spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• 1. incidence perioperative hypotension

  the number of hypotensive patients will be recorded

  Up to 4 hours after surgery

Secondary Outcomes (4)

• change in mean arterial blood pressure

  Up to 4 hours after surgery

• change in heart rate

  Up to 4 hours after surgery

• requirements of ephedrine and atropine

  Up to 4 hours after the procedure

• incidence of adverse effects

  Up to 24 hours surgery

Study Arms (2)

Group A (midodrine group)

ACTIVE COMPARATOR

Midodrine will be given orally with small sips of water one hour before arrival in the operation room before spinal anesthesia

Drug: Midodrine Oral Product

Group B (placebo group):

PLACEBO COMPARATOR

Inert tablet containing sugar (placebo) will be given orally with small sips of water one hour before arrival in the operation room before spinal anesthesia

Drug: Inert tablet containing sugar (placebo)

Interventions

Midodrine Oral Product DRUG

Patients will receive oral 10 mg tablet of midodrine with small sips of water one hour before arrival in the operation room. All patients will be monitored in with noninvasive blood pressure as well as continuous electrocardiogram (ECG) and pulse oximetry (SpO2). Before placement of spinal anesthesia, all patients will receive an IV bolus of 10mL/kg of Lactated Ringer's . Spinal anesthesia (midline puncture) will be performed in sitting position by a staff anesthetist at L3-L4 or L4-L5 with a 25-gauge Withacre needle injecting 12.5 mg of hyperbaric 0.5% bupivacaine (2.5 mL) with 10μg fentanyl. After injection,the patients will be turned supine.

Also known as: spinal anesthesia

Group A (midodrine group)

Inert tablet containing sugar (placebo) DRUG

: Patients will receive Inert tablet containing sugar (placebo) with small sips of water one hour before arrival in the operation room. All patients will be monitored in with noninvasive blood pressure as well as continuous electrocardiogram (ECG) and pulse oximetry (SpO2). Before placement of spinal anesthesia, all patients will receive an IV bolus of 10mL/kg of Lactated Ringer's . Spinal anesthesia (midline puncture) will be performed in sitting position by a staff anesthetist at L3-L4 or L4-L5 with a 25-gauge Withacre needle injecting 12.5 mg of hyperbaric 0.5% bupivacaine (2.5 mL) with 10μg fentanyl. After injection,the patients will be turned supine

Also known as: spinal anesthesia

Group B (placebo group):

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) status: 1 or 2 .
• Orthopedic surgery on the lower extremities

You may not qualify if:

• Pheochromocytoma. .Throtoxicosis. .Structural heart disease.
• Baseline blood pressure more than 140/90 .Acute kidney failure.
• Any contraindications to spinal anesthesia such as local infection and coagulopathy

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Egypt

Location

Related Publications (1)

• Alseoudy MM, Nasr MO, Abdelsalam TA. Efficacy of Preoperative Oral Midodrine in Preventing Hypotension After Spinal Anesthesia in Young Adults: A Randomized Controlled Trial. Anesth Analg. 2022 Nov 1;135(5):1089-1096. doi: 10.1213/ANE.0000000000006173. Epub 2022 Aug 10.

  PMID: 35950781 DERIVED

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Mahmoud M Alseoudy, MD

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation and administer oral tablet.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 20, 2020
• Study Start: June 8, 2020
• Primary Completion: December 29, 2020
• Study Completion: December 29, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

EG (1)