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

450 Participants Needed

Trial Summary

What is the purpose of this trial?

The drawbacks of chemical CO2 absorbers include the production of compounds harmful to patients that also lead into increased cost and environmental impact, as well as the daily disposal of compound special waste. Sustainable management of general anesthesia is a growing concern. Continually diluting anesthetic circuits, and the disposal of chemical granulate are serious environmental problems.

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 data supports the effectiveness of the drug memsorb for anesthesia management?

The research suggests that adding dexmedetomidine to pain management can reduce the need for other pain medications like meperidine, which may imply that memsorb, if it includes similar components, could be effective in managing anesthesia by potentially reducing the amount of other drugs needed. ^{1 2 3 4 5}

How is the drug memsorb different from other anesthesia management drugs?

Memsorb, also known as mesna, is unique because it acts as a protective agent against oxidative stress and tissue damage, which is not a common feature of typical anesthesia management drugs. It is known for its ability to neutralize harmful substances and protect tissues, which may offer additional benefits during anesthesia. ^{6 7 8 9 10}

Research Team

Orlando Hung, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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)

I speak English.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Immunosuppressive Effect of Intrathecal Morphine, Dexmedetomidine, or Both in Combination with Bupivacaine on Patients Undergoing Major Abdominal Cancer Surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Anesthesia Information Management Systems: An Underutilized Tool for Outcomes Research. [2018]

3. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Comparison of meperidine alone with meperidine plus dexmedetomidine for postoperative patient-controlled analgesia. [2010]

4. Japan pubmed.ncbi.nlm.nih.gov

[Anesthesia management may alter long-term outcome-review of recent reports]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes in perioperative medicine and anesthesiology. Into the next millennium. [2019]

6. Australia 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Review of Advances in Uroprotective Agents for Cyclophosphamide- and Ifosfamide-induced Hemorrhagic Cystitis. [2022]

8. Turkey pubmed.ncbi.nlm.nih.gov

The Effects of MESNA on the Facial Nerve, an Experimental Animal Study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The effects of sodium-2-mercaptoethanesulfonate application on the neural and neurovascular tissues: An experimental animal study. [2020]

10. England 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). [2019]