CLINICAL TRIALS PROFILE FOR METHOHEXITAL SODIUM

All Clinical Trials for METHOHEXITAL SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04504253 ↗	A Pilot Study of Creatine Monohydrate as an Augmenting Agent for ECT in Persons With Major Depressive Disorder	Recruiting	University of Utah	Phase 3	2020-08-03	We propose to determine if augmentation of electroconvulsive therapy (ECT) utilized for the treatment of major depressive disorder (MDD) with daily oral creatine will lead to an accelerated response to treatment, an overall increase in response rate, and will protect against cognitive adverse effects associated with ECT. We propose to conduct a two-arm, parallel, randomized, double-blinded, placebo-controlled trial, with a treatment group receiving 20 g oral loading dose of creatine for 1 week starting the day before initiating ECT, followed by 5 g oral creatine daily for roughly five weeks, including the approximately three-week ECT treatment course and a two-week follow-up period. Response to treatment will be assessed using the Quick Inventory of Depressive Symptomatology (QIDS) at each treatment and the 17-item Hamilton Depression Rating Scale (HAM-D17) at the end of each week.
NCT01200069 ↗	IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia	Terminated	Rutgers, The State University of New Jersey	Phase 4	2010-07-01	Post-procedure myalgia (muscle ache) is a well-known and common complication of Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exercise. The myalgias typically begin shortly after the procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of patients considered prevention significant and would be willing to pay a median of $33 out of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a further financial burden if these patients are unable to return to work or resume previous daily activities in the days following the procedure. An agent that could treat and possibly even prevent these myalgias has the potential to be very beneficial to these patients. IV ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever.

Clinical Trial Conditions for METHOHEXITAL SODIUM

Condition Name

Condition Name for METHOHEXITAL SODIUM
Intervention	Trials
Depression, Myalgia	1
Major Depressive Disorder	1

Condition MeSH

Condition MeSH for METHOHEXITAL SODIUM
Intervention	Trials
Depression	2
Depressive Disorder, Major	1
Depressive Disorder	1
Myalgia	1

Clinical Trial Locations for METHOHEXITAL SODIUM

Trials by Country

+

−

Trials by Country for METHOHEXITAL SODIUM
Location	Trials
United States	2

Trials by US State

+

−

Trials by US State for METHOHEXITAL SODIUM
Location	Trials
Utah	1
New Jersey	1

Clinical Trial Progress for METHOHEXITAL SODIUM

Clinical Trial Phase

Clinical Trial Phase for METHOHEXITAL SODIUM
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for METHOHEXITAL SODIUM
Clinical Trial Phase	Trials
Recruiting	1
Terminated	1

Clinical Trial Sponsors for METHOHEXITAL SODIUM

Sponsor Name

Sponsor Name for METHOHEXITAL SODIUM
Sponsor	Trials
Rutgers, The State University of New Jersey	1
University of Utah	1

Sponsor Type

Sponsor Type for METHOHEXITAL SODIUM
Sponsor	Trials
Other	2

Methohexital Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Methohexital sodium, a barbiturate anesthetic, has been in use for various medical procedures, including anesthesia induction and sedation. This article delves into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Current Studies

One of the most relevant ongoing studies compares the efficacy and safety of methohexital sodium versus propofol for sedation during direct current cardioversions (DCCV). This randomized, open-blinded, prospective study aims to evaluate the timeliness and safety of DCCVs using methohexital sodium.

• Objectives: The primary hypothesis is that methohexital sodium will result in a shorter time to recovery from sedation compared to propofol, as measured by the Ramsay Sedation Scale. Secondary hypotheses include no significant increase in adverse events with methohexital sodium[1].

• Methodology: The study will enroll 150 patients at Wake Forest Baptist Medical Center, randomizing them to receive either methohexital sodium or propofol. Patients with certain exclusion criteria, such as hemodynamic instability or recent sedation for transesophageal echocardiogram, will be excluded[1].

• Expected Outcomes: The study anticipates a significant reduction in recovery time with methohexital sodium, potentially leading to decreased healthcare costs due to reduced staff utilization and lower medication costs. It also expects fewer hemodynamic and respiratory side effects with methohexital sodium compared to propofol[1].

Pharmacological Profile

Mechanism of Action

Methohexital sodium is a barbiturate that acts rapidly, inducing sleep within 30 seconds of intravenous administration. It does not concentrate in fat depots, leading to fewer cumulative effects and quicker recovery compared to other barbiturates like thiopental and thiamylal[4].

• Metabolism and Excretion: Methohexital is metabolized in the liver through demethylation and oxidation, with side-chain oxidation being the primary biotransformation. It is excreted via the kidneys through glomerular filtration[3].

Safety and Efficacy

• Pediatric Use: The safety and effectiveness of methohexital sodium in pediatric patients, especially those under one month old, have not been established. Additional studies are needed to recommend its use in this population[3][4].

• Elderly Patients: Clinical studies have not identified significant differences in responses between elderly and younger patients, but caution is advised due to potential comorbidities such as obstructive pulmonary disease and cardiovascular conditions[4].

Market Analysis

Global Market Size and Trends

The global methohexital sodium market has been growing steadily. In 2018, the market size was valued at several million dollars, with a projected growth rate from 2019 to 2024.

• Market Segmentation: The market is segmented by company, country, and application/type. Key players in the industry are profiled, including their product specifications, capacity, production value, and market shares[5].

• Regional Analysis: The market is analyzed across various regions, including the Asia-Pacific, USA, EU, and Japan. The report provides insights into the competitive landscape, supply and demand dynamics, and market development trends[2][5].

Market Forecast

The global methohexital sodium market is expected to grow, driven by increasing demand for efficient and safe anesthetic agents. The forecast from 2019 to 2024 indicates a continued growth trend, with the market expected to reach a significant value by the end of 2024[5].

• Upstream and Downstream Analysis: The report analyzes upstream raw materials, downstream demand, and current market dynamics. It also makes proposals for new projects in the methohexital sodium industry, evaluating their feasibility[5].

Economic Impact

Cost Considerations

The use of methohexital sodium could lead to significant institutional savings due to its lower cost per unit compared to propofol. Quicker recovery times also reduce staff utilization costs, making it a more economical option for sedation in procedures like DCCV[1].

• Market Competition: The competitive landscape of the methohexital sodium industry is characterized by key players competing based on product quality, pricing, and market share. The report provides a detailed analysis of market competition by company and country[2][5].

Key Takeaways

• Clinical Trials: Ongoing studies compare methohexital sodium with propofol for sedation during DCCV, aiming to establish its safety and efficacy.
• Pharmacological Profile: Methohexital sodium has a rapid onset and shorter duration of action, with fewer cumulative effects compared to other barbiturates.
• Market Analysis: The global methohexital sodium market is growing, driven by increasing demand and competitive market dynamics.
• Economic Impact: The use of methohexital sodium can lead to significant cost savings due to its lower cost and quicker recovery times.

FAQs

What is the primary objective of the ongoing clinical trial comparing methohexital sodium and propofol?

The primary objective is to determine if methohexital sodium results in a shorter time to recovery from sedation compared to propofol during direct current cardioversions.

How does methohexital sodium differ from other barbiturate anesthetics?

Methohexital sodium is at least twice as potent on a weight basis and has a shorter duration of action compared to other barbiturates like thiopental and thiamylal. It also does not concentrate in fat depots, leading to quicker recovery[4].

What are the potential economic benefits of using methohexital sodium?

The use of methohexital sodium can lead to significant institutional savings due to its lower cost per unit and quicker recovery times, which reduce staff utilization costs[1].

Is methohexital sodium safe for use in pediatric patients?

The safety and effectiveness of methohexital sodium in pediatric patients, especially those under one month old, have not been established. Additional studies are necessary to recommend its use in this population[3][4].

What is the expected growth trend for the global methohexital sodium market?

The global methohexital sodium market is expected to grow from 2019 to 2024, driven by increasing demand and competitive market dynamics[5].

Sources

1. ClinicalTrials.gov: "Comparison of Bolus Dosing of Methohexital and Propofol for Sedation During Direct Current Cardioversion" - Protocol Version 27Aug2019.
2. MarketPublishers.com: "Global and Chinese Methohexital Sodium Industry, 2018 Market Research Report".
3. FDA.gov: "BREVITAL® (methohexital sodium) for injection, USP" - Label.
4. Drugs.com: "Methohexital Sodium: Package Insert / Prescribing Info".
5. MarketPublishers.com: "Global Methohexital Sodium Market Report 2019 - Market Size, Share, Price, Trend and Forecast".