Inhalational vs Intravenous Anesthesia for Colorectal Cancer Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Disqualifiers: Rectal adenocarcinoma, Psychiatric illness, Infections, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day (surgery)

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of anesthesia—inhalational (breathed in) and intravenous (through a needle)—affect recovery and the immune system in individuals undergoing colon cancer surgery. Researchers aim to determine if the anesthesia type influences recovery or impacts cancer recurrence. Participants may qualify if they have confirmed colon cancer and plan to undergo surgery (referred to as "Surgical Procedure" or "Paraplatin") for removal. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments in this study—sevoflurane-fentanyl-propofol and fentanyl-propofol—are generally well-tolerated by patients. Studies have found that the sevoflurane-fentanyl-propofol combination is safe for use during surgeries. However, past research suggests that propofol may lead to slightly better long-term survival rates compared to sevoflurane.

For the fentanyl-propofol combination, research indicates they work well together to provide effective sedation for medical procedures. This combination is often chosen for its efficiency, and studies have not identified any major safety concerns.

Since this trial is in Phase 2, earlier tests have shown these treatments to be safe enough to continue. However, more information is needed to fully confirm safety. Participants should feel reassured by the existing research but should always discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these anesthesia methods for colorectal cancer surgery because they explore different approaches to sedation that might enhance patient outcomes. The trial compares inhalational anesthesia using sevoflurane with intravenous sedation using fentanyl and propofol. Unlike traditional methods that often rely solely on intravenous sedation, inhalational anesthesia could offer more stable control of anesthesia levels during surgery. This could potentially lead to quicker recovery times and fewer side effects. By comparing these methods, researchers hope to determine which approach provides the best balance of effectiveness and safety for patients undergoing colorectal cancer surgery.

What evidence suggests that this trial's anesthesia methods could be effective for colon cancer surgery?

Research has shown that the type of anesthesia can affect recovery after colorectal cancer surgery. In this trial, participants will receive different anesthesia combinations. Arm I uses sevoflurane with fentanyl citrate and propofol, while Arm II uses fentanyl citrate and propofol without sevoflurane. Studies have found that patients receiving propofol, either with sevoflurane or fentanyl, often experience better long-term survival rates. For example, one study found that the 1-year survival rate for colon cancer patients was nearly 10% higher with propofol anesthesia. Additionally, using propofol with fentanyl proves more effective and safer than using propofol alone for similar procedures. These findings suggest that both anesthesia combinations in this trial may improve recovery and outcomes for colorectal cancer surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Luke V Selby

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

This trial is for adults (18+) with colon cancer who are medically fit for surgery and can complete study questionnaires. They must be willing to follow the study procedures throughout its duration, have an ECOG status of 0-2, and provide written consent. Excluded are those with allergies to eggs or soy, a history of malignant hyperthermia, rectal adenocarcinoma diagnosis, enrollment in another therapeutic trial, severe psychiatric or social issues affecting compliance, active serious infections within two weeks prior to treatment start date, prisoner status, inflammatory bowel disease diagnosis or planned complex surgeries.

Inclusion Criteria

I am medically cleared for surgery to remove part of my colon.

I, or my legal representative, can understand the study and agree to sign the consent form.

You are able to satisfactorily complete the specified questionnaires.

Exclusion Criteria

I have been diagnosed with rectal cancer.

I am scheduled for a complex surgery involving multiple organs.

I have not had surgery for polyps that couldn't be fully removed or had incomplete removals without confirmed cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either inhalational anesthesia with sevoflurane and fentanyl or intravenous anesthesia with fentanyl and propofol during surgery. Blood and tissue samples are collected.

1 day (surgery)

1 visit (in-person)

Immediate Post-operative Recovery

Patient recovery is monitored, including pain management, nausea, and return of GI function. Blood samples are collected for ctDNA and inflammatory markers.

2-4 days

In-patient hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of post-operative recovery, immune suppression, and survival.

6 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are followed up yearly for 5 years to assess long-term outcomes such as disease-free survival and overall survival.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Electronic Health Record Review
• Surgical Procedure

Trial Overview The VIVA Study is testing whether inhalational anesthesia (breathed in) versus total intravenous anesthesia (TIVA) affects recovery from colon cancer surgery and impacts the immune system post-surgery. It aims to determine if these types of anesthesia influence surgical recovery outcomes or cancer recurrence rates.

How Is the Trial Designed?

Group I: Arm II (fentanyl citrate, propofol) Experimental Treatment 6 Interventions

Patients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.

Group II: Arm I (sevoflurane, fentanyl citrate, propofol) Active Control 7 Interventions

Patients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.

Surgical Procedure is already approved in United States, European Union for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Lung cancer
• Head and neck cancer
• Brain cancer
• Neuroblastoma
• Testicular cancer
• Breast cancer
• Cervical cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Lung cancer
• Head and neck cancer
• Brain cancer
• Neuroblastoma
• Testicular cancer
• Breast cancer
• Cervical cancer

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A systematic review of 8 studies involving 10,696 cancer surgery patients suggests that total intravenous anesthesia (TIVA) may be associated with lower overall mortality compared to inhalational anesthesia (INHA), with one study reporting a hazard ratio of 0.85 for TIVA, indicating a potential survival benefit.

TIVA was also linked to a significantly lower rate of pulmonary complications compared to INHA, while other postoperative complications were similar between the two anesthesia methods, suggesting TIVA might be the safer option for cancer surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of cancer surgery after inhalational and intravenous anesthesia: A systematic review. Soltanizadeh, S., Degett, TH., Gögenur, I.[2018]

In a study of 11,560 patients undergoing colorectal cancer surgery, those exposed to inhalation anaesthesia had a weakly increased risk of cancer recurrence compared to those who received intravenous anaesthesia, with a hazard ratio of 1.12.

There was no significant difference in all-cause mortality or disease-free survival between the two anaesthesia types, suggesting that while inhalation anaesthesia may influence recurrence, it does not appear to affect overall survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalation or total intravenous anaesthesia and recurrence after colorectal cancer surgery: a propensity score matched Danish registry-based study. Hasselager, RP., Hallas, J., Gögenur, I.[2021]

Intravenous anesthesia was performed on 1160 breast cancer patients between 1982 and 1989, showing significant advantages over endotracheal anesthesia, including fewer complications and quicker recovery times.

The study suggests that intravenous anesthesia is a preferred method for surgical treatment in cancer patients who do not require muscle relaxation, due to its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[General anesthesia during surgery of breast cancer]. Kvetko, RN., Polevanskaia, NK., Zagoruĭko, VK., et al.[2006]

In a study of 78 colorectal cancer patients, sevoflurane inhalation combined with epidural anesthesia resulted in more stable mean arterial pressure and heart rate during surgery compared to propofol intravenous general anesthesia, particularly at critical time points post-surgery.

Patients receiving sevoflurane and epidural anesthesia experienced significantly shorter recovery times, including faster extubation and hospital stays, and showed quicker recovery of cognitive function after surgery, suggesting it may be a superior anesthetic option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of sevoflurane inhalation combined with epidural anesthesia in patients with colorectal cancer and its effect on postoperative perceptual function. Zhang, X., Jiang, H.[2022]

Total intravenous anesthesia (TIVA) using propofol is associated with a significantly lower risk of metastasis and recurrence after cancer surgery compared to inhalational anesthesia (IHNA), with a relative risk of 0.61 based on a systematic review and meta-analysis of clinical and pre-clinical studies involving various cancer surgeries.

Patients receiving TIVA also showed lower levels of the inflammatory cytokine IL-6 post-surgery, which is linked to cancer metastasis, suggesting that propofol may have a protective effect against cancer progression compared to inhaled anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Effect of General Anesthetics in Cancer Surgery: Meta-Analysis of Postoperative Metastasis and Inflammatory Cytokines. Li, R., Mukherjee, MB., Jin, Z., et al.[2023]

A meta-analysis of 12 randomized controlled trials involving patients with colorectal cancer showed that sevoflurane combined with propofol significantly reduces the incidence of postoperative nausea and vomiting (PONV) compared to other anesthetic methods.

The study also found that this combination anesthesia resulted in better hemodynamic stability, as indicated by changes in heart rate and mean arterial pressure, while maintaining a moderate level of sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sevoflurane and propofol on postoperative nausea and vomiting in patients with colorectal cancer placed under general anesthesia: a systematic review and meta-analysis. Wu, L., Li, Y., Si, J.[2023]

In a study of 1538 patients who underwent gastric cancer surgery, propofol-based total intravenous anesthesia (TIVA) did not show a significant difference in 1-year overall mortality compared to inhalation anesthesia, indicating similar safety profiles for both methods.

The risk of 1-year cancer-related mortality was also comparable between the TIVA and inhalation anesthesia groups, suggesting that the choice of anesthetic may not impact long-term cancer outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of 1-year mortality after gastric cancer surgery: Total intravenous anesthesia versus volatile anesthesia. Oh, TK., Kim, HH., Jeon, YT.[2020]

Surgery for cancer can sometimes lead to tumor growth and spread, making the choice of anesthesia during the perioperative period crucial for patient outcomes.

This review focuses on the effects of different anesthetic agents, particularly volatile inhalational agents and propofol, on cancer progression, highlighting the need for more prospective studies to guide best practices in anesthesia for cancer surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General Anesthetics in Cancer Surgery: Can Anesthesiologists Help the Patient with More than a Safe Sleep. Bonvini, JM.[2022]

A survey of 275 anaesthetists in Australasia revealed that only 18% use total intravenous anaesthesia (TIVA) for most cases, despite 43% believing it may lead to less cancer recurrence compared to inhalational anaesthesia.

The study highlights a willingness among anaesthetists to use TIVA more frequently if setup were easier, indicating a need for further research to clarify its benefits in cancer surgery and support a large randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalational versus propofol-based total intravenous anaesthesia: practice patterns and perspectives among Australasian anaesthetists. Lim, A., Braat, S., Hiller, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4116765/

The choice of anaesthetic—sevoflurane or propofol—and ... The 1-year survival for patients operated for colon cancer was almost 10% higher after propofol anaesthesia. However, after adjustment for several confounders, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0104001415000196

Colonoscopy sedation: clinical trial comparing propofol ... The combination of midazolam, fentanyl, and propofol for colonoscopy sedation reduces propofol consumption and provides greater patient satisfaction.

3. spandidos-publications.com spandidos-publications.com/10.3892/ol.2018.9801

Application of remifentanil combined with propofol in the ... This study was used to evaluate the efficacy and safety of remifentanil combined with propofol in the diagnosis and treatment of colon cancer ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2021/9955488

Propofol Combined with Fentanyl Is Superior to ... Sedation with propofol combined with fentanyl was more effective and safer than that with propofol alone in painless gastrointestinal endoscopy.

5. ujms.net ujms.net/index.php/ujms/article/download/5885/11689/

The choice of anaesthetic—sevoflurane or propofol—and ... The 1-year survival for patients operated for colon cancer was almost 10% higher after propofol anaesthesia.

6. e-ce.org e-ce.org/journal/view.php?number=8019

a randomized trial comparing propofol-based sedation ... The endoscopists reported a higher level of ease with the colonoscopy procedure (mean on a 5-point scale, 1.2 vs. 1.72; p=0.028) and the overall ...

7. map.amegroups.org map.amegroups.org/article/view/4056/html

AB045. 98. Fentanyl versus pethidine used in combination ... Results: A total of 296 patient's data were analyzed. Both groups of patients received midazolam mean dosage of 4.5 mg (range, 2–8 mg). The 148 patients ...