Anesthesia Choice for Gynecologic Cancer Surgery

Overseen By Anna Woods

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Florida

Disqualifiers: Increased intraocular pressure, recent eye surgery, 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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different types of anesthesia affect eye pressure during surgery for gynecologic cancer. It compares two anesthesia methods: total intravenous anesthesia (TIVA), which uses a mix of drugs given through an IV, and balanced anesthesia, which uses both IV drugs and gases. The researchers aim to determine which method maintains lower eye pressure, potentially reducing surgical risks. Women planning to undergo robotic surgery for gynecologic cancer and cleared by a pre-anesthesia clinic are suitable candidates for this study. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

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 is the safety track record for these anesthetic techniques?

Research shows that both balanced anesthesia and TIVA (total intravenous anesthesia) are generally safe for individuals undergoing surgery for gynecologic cancers. Balanced anesthesia, which uses a mix of drugs like propofol and isoflurane, is commonly used and well-tolerated in these surgeries. Studies have not reported any severe side effects associated with it.

For TIVA, research suggests it might offer benefits beyond safety. Studies indicate that TIVA, which uses drugs like propofol without inhaled gases, is linked to better survival rates in cancer surgeries. These studies have not reported major safety concerns.

Both anesthesia methods aim to keep patients stable during surgery. While balanced anesthesia is widely used, TIVA is gaining attention for its potential to improve outcomes in cancer surgeries. Past research has used both options safely, suggesting they are well-tolerated in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it compares two anesthesia techniques for gynecologic cancer surgery: Balanced anesthesia and TIVA (Total Intravenous Anesthesia). Balanced anesthesia uses a mix of inhaled gases and intravenous drugs to maintain sedation, while TIVA relies solely on intravenous drugs, avoiding inhaled anesthetics altogether. This difference could impact patient recovery times and side effects. By understanding these variations, researchers hope to determine which method offers better outcomes and safety, making surgeries more effective and comfortable for patients.

What evidence suggests that this trial's anesthetic techniques could be effective in managing intraocular pressure during gynecologic cancer surgery?

This trial will compare balanced anesthesia with total intravenous anesthesia (TIVA) for gynecologic cancer surgery. Research has shown that both balanced anesthesia and TIVA can affect eye pressure during surgery. Studies suggest that TIVA, using drugs like propofol, may improve outcomes in cancer surgeries, such as longer survival and a reduced risk of cancer recurrence. Propofol-based TIVA is also associated with fewer complications compared to inhalation anesthesia. However, balanced anesthesia is widely used and maintains patient stability during surgery. Evidence indicates that TIVA might offer better long-term outcomes in some cancer surgeries, but both methods effectively manage eye pressure during gynecologic cancer surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Sonia Mehta, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for women over 18 who are set to have robotic surgery for suspected or confirmed gynecological cancer. They must be cleared by the pre-anesthesia clinic and agree to all study procedures. It's not open to those with certain eye conditions, recent eye surgery, or known high intraocular pressure.

Inclusion Criteria

I am scheduled for robotic surgery for suspected or confirmed gynecological cancer.

I have been cleared for surgery by the anesthesia team.

I am over 18, have a gynecological cancer, and am cleared for surgery.

Exclusion Criteria

Subjects for whom an ophthalmologist has determined cannot undergo intraocular pressure measurement

I have high eye pressure or recent eye surgery, making eye pressure tests not possible.

I have been treated or diagnosed for high eye pressure before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Day of Surgery

Intraocular Pressure (IOP) is measured at multiple time points during the surgical procedure using different anesthetic techniques

1 day

1 visit (in-person)

Post-operative Monitoring

Post-operative IOP measurements are taken, and any abnormal readings prompt an ophthalmology consult

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any ongoing ocular issues and effectiveness of the anesthetic techniques

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Balanced anesthesia
• TIVA

Trial Overview

The study measures how much a woman's eye pressure changes during robotic cancer surgery when using two types of anesthesia: total IV anesthesia (TIVA) versus conventional balanced anesthesia. The goal is to see which method better prevents an increase in eye pressure.

How Is the Trial Designed?

Group I: TIVA anesthesia Experimental Treatment 1 Intervention

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg) to limit any discomfort caused by the propofol injection. After endotracheal intubation, intravenous infusion of propofol, lidocaine, ketamine or narcotic as deemed appropriate by anesthesiologist. There will be no inhalation anesthetic used. Ventilation with oxygen and air mixture (50%/50%) and titrated to keep the mean arterial pressure within 20% of its preinduction value. Muscle relaxation maintain using Aliquots of rocuronium to 0 to 1 train-of-4 twitch response of adductor pollicis. During surgery, mechanical ventilation using pressure-controlled mode (peak inspiratory pressure 30 cm H2O). We aim for Tidal volume of 5-7 ml/Kg of ideal body weight with a positive end-expiratory pressure of 5 cm H2O, and a respiratory rate to maintain end-tidal carbon dioxide between 30 to 40 mm Hg.

Group II: Balanced anesthesia Active Control 1 Intervention

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg) to limit any discomfort caused by the propofol injection. After endotracheal intubation, the depth of anesthesia will be maintained at a minimum alveolar concentration of 1 to 1.25 using isoflurane in oxygen and air mixture (50%/50%) and titrated to keep the mean arterial pressure within 20% of its preinduction value. Muscle relaxation maintain using Aliquots of rocuronium to 0 to 1 train-of-4 twitch response of adductor pollicis. During the surgery, subjects will be mechanically ventilated using pressure-controlled mode (peak inspiratory pressure 30 cm H2O). We aim for Tidal volume of 5-7 ml/Kg of ideal body weight with a positive end-expiratory pressure of 5 cm H2O, and a respiratory rate to maintain end-tidal carbon dioxide between 30 to 40 mm Hg.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

In a study of 253,003 patients undergoing major cancer surgery, propofol-based total intravenous anesthesia (TIVA) was associated with lower 90-day and one-year mortality rates compared to inhalation anesthesia, indicating better survival outcomes.

Specifically, TIVA showed significant benefits in reducing 90-day mortality for patients undergoing gastric, colorectal, and pancreatic cancer surgeries, suggesting its effectiveness in these high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol-based intravenous anesthesia is associated with improved survival outcomes after major cancer surgery: a nationwide cohort study in South Korea. Oh, TK., Jo, H., Song, IA.[2023]

In a study of 1,508 patients with early-stage non-small cell lung cancer (NSCLC), those who received propofol-based total intravenous anesthesia (TIVA) had significantly better recurrence-free survival (RFS) of 7.7 years compared to 6.8 years for those who received inhalation anesthesia.

TIVA also resulted in improved overall survival (OS) with a median of 8.4 years versus 7.3 years for inhalation anesthesia, indicating that TIVA may be a more effective anesthetic approach for patients undergoing curative surgery for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of total intravenous versus inhalation anesthesia on long-term oncological outcomes in patients undergoing curative resection for early-stage non-small cell lung cancer: a retrospective cohort study. Seo, KH., Hong, JH., Moon, MH., et al.[2023]

Patients undergoing cancer surgery with propofol-based total intravenous anesthesia (TIVA) showed significantly better overall survival compared to those receiving volatile anesthesia, with a hazard ratio of 0.79, indicating a 21% reduction in the risk of death.

No significant difference in recurrence-free survival was found between the two anesthesia types, suggesting that while propofol may improve overall survival, it does not necessarily affect the likelihood of cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthesia and Long-term Oncological Outcomes: A Systematic Review and Meta-analysis. Chang, CY., Wu, MY., Chien, YJ., et al.[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]

In a study of 312,985 cancer surgery patients, there was no significant difference in overall survival between those who received propofol-based total intravenous anesthesia (TIVA) and those who received inhalational anesthesia (IA), suggesting that the type of anesthesia does not impact long-term outcomes after surgery.

While some single-center studies indicated a potential survival advantage for TIVA, multicenter studies did not support this finding, highlighting the need for further research to clarify the relationship between anesthesia type and cancer surgery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Propofol-based Total Intravenous Anesthesia Versus Inhalation Anesthesia on Long-term Survival After Cancer Surgery in a Nationwide Cohort. Yoon, S., Jung, SY., Kim, MS., et al.[2023]

In a study of 165 patients undergoing elective surgery for epithelial ovarian cancer, those who received propofol anesthesia had significantly better survival rates compared to those who received desflurane anesthesia, with a hazard ratio of 0.52, indicating a 48% reduction in the risk of death.

Patients receiving propofol also experienced less postoperative recurrence and metastasis, suggesting that the choice of anesthetic may influence long-term oncological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol-Based Total Intravenous Anesthesia is Associated with Better Survival than Desflurane Anesthesia in Epithelial Ovarian Cancer Surgery: A Retrospective Cohort Study. Tseng, WC., Lee, MS., Lin, YC., et al.[2021]

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Effects of anesthesia on long-term survival in cancer surgery

Propofol-based anesthesia may be associated with improved OS and RFS than inhalation anesthesia in some cancer surgeries.

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Anesthesia and Cancer, Friend or Foe? A Narrative Review

Many studies have suggested some anesthetic agents have the potential to be harmful and increase the risk of recurrence or disease progression ...