Memsorb for Anesthesia Management

(memsorb Trial)

Overseen By Vera Lloyd

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: DMF Medical Incorporated

Disqualifiers: Pregnancy, Emergency surgery, Respiratory disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 12 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new CO2 filter called memsorb, which could make anesthesia safer and more eco-friendly. The goal is to reduce harmful chemicals and waste produced during surgery. Participants will either use the memsorb filter or the standard CO2 absorber to compare results. Ideal candidates are English-speaking patients with low to medium anesthesia risk, not undergoing emergency surgery, and without severe breathing issues.

As an unphased trial, this study offers a unique opportunity to contribute to advancements in safer, more sustainable surgical practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that memsorb is safe for anesthesia management?

Research shows that memsorb, a new filter for removing CO2 during anesthesia, is very safe. Studies have found that the risk of using memsorb remains very low due to close monitoring by medical staff. So far, patients using memsorb have not reported any serious side effects. This makes it a promising option for those concerned about the safety of traditional CO2 absorbers, which can produce harmful chemicals. While memsorb is still undergoing testing, current evidence suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Memsorb is unique because it introduces an innovative CO2 filtering technology for anesthesia management. Unlike traditional CO2 absorbers that rely on chemical reactions to eliminate carbon dioxide, Memsorb uses a new filtration method that aims to be more efficient and less prone to complications like compound A production or desiccation. Researchers are excited about Memsorb because it could lead to safer and more reliable anesthesia management, minimizing risks and potentially improving patient outcomes during surgeries.

What evidence suggests that memsorb is effective for anesthesia management?

Research has shown that Memsorb, the new CO2 filter evaluated in this trial, effectively removes carbon dioxide (CO2) from anesthesia machines without harmful chemicals. Studies have demonstrated that it can remove CO2 at a rate of up to 240 mL per minute, which is highly efficient. This device uses technology similar to that of membrane oxygenators, already trusted in medical settings. Early results suggest it is safe and effective for patients under anesthesia. Memsorb not only ensures patient safety but also benefits the environment by avoiding chemical waste. Participants in this trial will receive either standard care using Memsorb or standard care with a standard CO2 absorber. ^{2 3 5 6 7}

Who Is on the Research Team?

Orlando Hung, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for English-speaking patients with a low to medium risk status (Class I, II, III) according to the American Society of Anesthesiologists. It's not suitable for pregnant individuals, high-risk patients (Class IV), those needing emergency surgery, or people with elevated brain pressure or severe respiratory diseases like COPD and asthma.

Inclusion Criteria

American Society of Anesthesiologists Physical Status Class I, II, III (low-medium risk patient)

Exclusion Criteria

Self-reported as pregnant

American Society of Anesthesiologists Physical Status Class IV (high risk patient)

I am scheduled for an emergency surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard care using either the memsorb CO2 filter or a standard CO2 absorber during surgery

Up to 12 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurements of various physiological parameters

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• memsorb

Trial Overview The study is testing 'memsorb', an innovative method aimed at removing CO2 from anesthetic circuits without using chemical granulate. This could potentially reduce harmful compounds, costs, environmental impact and the need for daily disposal of special waste.

How Is the Trial Designed?

Group I: memsorb Experimental Treatment 1 Intervention

Patients agree to receive standard care but using memsorb, the new CO2 filter evaluated in this study.

Group II: Control Active Control 1 Intervention

Patients receive standard care with a standard CO2 absorber and agree to include their data in the study.

Who Is Running the Clinical Trial?

DMF Medical Incorporated

Lead Sponsor

Trials

3

Recruited

520+

Published Research Related to This Trial

Cyclophosphamide and ifosfamide, commonly used for treating cancers and autoimmune diseases, can cause a serious side effect known as hemorrhagic cystitis, which is inflammation and bleeding in the bladder.

Mesna is the primary drug used to protect against this side effect by neutralizing a harmful metabolite called acrolein, but ongoing research is exploring new uroprotective agents to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Advances in Uroprotective Agents for Cyclophosphamide- and Ifosfamide-induced Hemorrhagic Cystitis. Matz, EL., Hsieh, MH.[2022]

Topical administration of MESNA solution at both 25% and 100% concentrations resulted in increased inflammation around the facial nerve, indicating a potential for irritation or tissue response.

Despite the inflammation observed, there were no significant effects on facial nerve function, as measured by reflex scores, suggesting that MESNA does not cause neurotoxicity in the doses tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of MESNA on the Facial Nerve, an Experimental Animal Study. Baklacı, D., Kum, RO., Kulaçoğlu, S., et al.[2020]

Mesna is a safe and non-toxic compound that effectively prevents bladder damage caused by oxazaphosphorine chemotherapy drugs in experimental models, specifically in rats.

Importantly, mesna does not interfere with the overall effectiveness of oxazaphosphorines or other chemotherapy agents like doxorubicin and methotrexate, ensuring that cancer treatment remains effective while protecting the bladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies on the urotoxicity of oxazaphosphorine cytostatics and its prevention--III. Profile of action of sodium 2-mercaptoethane sulfonate (mesna). Brock, N., Pohl, J., Stekar, J., et al.[2019]

The use of Anesthesia Information Management Systems (AIMS) for perioperative outcomes research has significantly increased since 2001, highlighting its growing importance in understanding patient outcomes during surgery.

AIMS have proven effective in addressing complex clinical issues, such as risk stratification and rare complications like malignant hyperthermia, which traditional research methods struggle to analyze due to the unique challenges of anesthesia practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthesia Information Management Systems: An Underutilized Tool for Outcomes Research. Deng, F., Hickey, JV.[2018]

In a study of 40 patients undergoing elective abdominal surgery, the combination of dexmedetomidine with meperidine in a patient-controlled analgesia (PCA) device significantly reduced postoperative pain scores compared to meperidine alone.

Patients receiving the meperidine-dexmedetomidine combination consumed less meperidine both in the postanesthesia care unit and up to 24 hours after surgery, indicating that dexmedetomidine enhances the efficacy of meperidine for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of meperidine alone with meperidine plus dexmedetomidine for postoperative patient-controlled analgesia. Altindis, NT., Karaaslan, D., Peker, TT., et al.[2010]

In a study involving guinea pigs, the application of MESNA at concentrations of 50% and 100% did not result in any observable morphological changes in neural and neurovascular structures, indicating its safety for neurotological applications.

The findings suggest that MESNA, even at high concentrations, does not exhibit toxic effects on brain tissue, supporting its use as a protective agent in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of sodium-2-mercaptoethanesulfonate application on the neural and neurovascular tissues: An experimental animal study. Ant, A., Karamert, R., Kulduk, G., et al.[2020]

Mesna effectively prevents oxidative stress in the intestinal mucosa caused by ischemia-reperfusion injury, with its protective effects being more pronounced when administered orally and in a time- and dose-dependent manner.

The mechanism of mesna's action involves the inhibition of nuclear factor-kappaB (NF-kappaB) activation, which is linked to its ability to mitigate oxidative damage in the intestine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylaxis with mesna prevents oxidative stress induced by ischemia reperfusion in the intestine via inhibition of nuclear factor-kappaB activation. Ypsilantis, P., Tentes, I., Lambropoulou, M., et al.[2018]

In a study of 90 cancer surgical patients, intrathecal dexmedetomidine showed less immunosuppressive effects compared to morphine alone and the combination of morphine and dexmedetomidine, particularly in reducing cellular immunity markers post-surgery.

The use of dexmedetomidine also resulted in more favorable inflammatory mediator profiles, with lower levels of IL-10 and IL-1beta compared to morphine, suggesting it may be a better option for managing postoperative pain without compromising immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppressive Effect of Intrathecal Morphine, Dexmedetomidine, or Both in Combination with Bupivacaine on Patients Undergoing Major Abdominal Cancer Surgery. Kamal, SM., Mohamed, SA., Fares, KM., et al.[2022]

Outcomes research in perioperative medicine and anesthesiology is shifting from traditional clinical outcomes to more comprehensive assessments of patient-related outcomes, which could enhance the quality of care.

Current trends in evidence-based medicine (EBM) are expected to improve both individual patient experiences and overall healthcare quality, highlighting new opportunities for research in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes in perioperative medicine and anesthesiology. Into the next millennium. Wu, CL., Fleisher, LA.[2019]

Recent studies suggest that the management of anesthesia during surgery can significantly impact the long-term outcomes for patients, highlighting the need for careful consideration of anesthetic depth and techniques.

Emerging evidence indicates that medications such as beta-blockers, alpha-agonists, statins, and proper glucose control may also play a crucial role in improving postoperative recovery and long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anesthesia management may alter long-term outcome-review of recent reports]. Kudoh, I., Ohmura, A.[2018]

Citations

1. withpower.com withpower.com/trial/phase-respiratory-aspiration-2-2021-0a242

Memsorb Filter System for Anesthesia Environmental Impact This trial tests Memsorb, a new device that removes CO2 from anesthesia systems without harmful chemicals. It targets patients in busy surgical centers to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35103886/

Memsorb™, a novel CO2 removal device part II Memsorb™ (DMF Medical, Halifax, Canada) is a novel device based upon membrane oxygenator technology designed to eliminate CO2 from exhaled gas ...

3. memsorb.com memsorb.com/sites/default/files/2024-11/F-RA-23%20Safety%20and%20Performance%20-%20memsorb%20V03%202024-11-22.pdf

1. Device identification and general information 2. Intended ... - The established performance and functionality of memsorbTM is safe and effective for use when removing CO2 from the patient rebreathing ...

4. withpower.com withpower.com/trial/phase-2017-c5c80

Memsorb for Anesthesia Management · Info for Participants The memsorb medical study, being run by DMF Medical Incorporated, needs participants to evaluate whether memsorb will have tolerable side effects & efficacy ...

5. researchgate.net researchgate.net/publication/358190017_Memsorb_a_novel_CO2_removal_device_part_I_in_vitro_performance_with_the_Zeus_IER

Memsorb™, a novel CO2 removal device part I In vitro data found that Memsorb successfully removed CO 2 with VCO 2 up to 240 mL/min if an F I CO 2 of 0.5% was accepted. ... ... Technical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03014336

A New and Innovative Method for CO2 Removal in Anesthetic ... DMF Medical has developed a next-generation CO2 filter in order to address the safety issues with current chemical CO2 absorbers in anesthesia. memsorb uses ...

7. link.springer.com link.springer.com/article/10.1007/s12630-023-02563-7

Comparison of the novel membrane-based carbon dioxide ... The aim of this study was to test the performance of the memsorb device for CO2 removal from a standard anesthesia machine vis-à-vis a CGA using ...