Anesthesia Choice for Gynecologic Cancer Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Florida
Disqualifiers: Increased intraocular pressure, recent eye surgery, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Steep Trendelenburg positioning and insufflation of the abdominal cavity have shown to increase intra ocular pressure. Different anesthetic techniques can alter intra ocular pressure and a small pilot study showed decrease in Intraocular Pressure (IOP) in robotic case in steep Trendelenburg with IV anesthetics (TIVA).
We want to quantify the degree of change in Intraocular Pressure (IOP) in female patients undergoing robotic procedures for cancer. We want to detect the difference in increase of pressure with total IV anesthesia versus conventional balanced anesthesia
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 treatment Balanced anesthesia, General anesthesia, Conventional anesthesia, TIVA, Total Intravenous Anesthesia, Propofol-based anesthesia for gynecologic cancer surgery?
Research suggests that propofol-based total intravenous anesthesia (TIVA) may improve long-term survival outcomes after cancer surgeries compared to inhalation anesthesia, as seen in studies involving various types of cancer surgeries.
12345Is propofol-based total intravenous anesthesia (TIVA) safe for use in humans?
Propofol-based total intravenous anesthesia (TIVA) has been studied in various cancer surgeries and is generally considered safe for use in humans. The research primarily focuses on comparing its effectiveness and long-term outcomes with inhalation anesthesia, but no significant safety concerns have been highlighted in these studies.
12345How does the anesthesia treatment for gynecologic cancer surgery differ from other treatments?
The treatment uses propofol-based total intravenous anesthesia (TIVA), which has been associated with better survival outcomes compared to inhalation anesthesia in various cancer surgeries, including ovarian cancer. This approach may lead to improved long-term survival and reduced recurrence and metastasis after surgery.
12456Eligibility Criteria
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.
+2 more
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.
+1 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: TIVA anesthesiaExperimental Treatment1 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 anesthesiaActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
References
Retrospective analysis of 1-year mortality after gastric cancer surgery: Total intravenous anesthesia versus volatile anesthesia. [2020]It remains controversial whether propofol-based total intravenous anesthesia (TIVA) or inhalation anesthesia is associated with better outcomes after cancer surgery. We investigated whether there is a difference in the 1-year overall or cancer-related mortality between propofol-based TIVA and inhalation anesthesia in patients who underwent gastric cancer surgery.
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. [2023]Propofol-based total intravenous anesthesia (TIVA) improves long-term outcomes after cancer surgery compared with inhalation anesthesia. However, its effect on patients undergoing non-small cell lung cancer (NSCLC) surgery remains unclear. We aimed to compare the oncological outcomes of TIVA and inhalation anesthesia after curative resection of early-stage NSCLC.
Anesthesia and Long-term Oncological Outcomes: A Systematic Review and Meta-analysis. [2023]Whether propofol elicits a survival benefit over volatile anesthetics during cancer surgery remains inconclusive. The primary aim of this systematic review and meta-analysis is to compare the effects of propofol-based total intravenous anesthesia (TIVA) with any volatile anesthesia on long-term oncological outcomes. The secondary aim is to compare propofol-based TIVA with specific volatile agents on long-term oncological outcomes.
Propofol-based intravenous anesthesia is associated with improved survival outcomes after major cancer surgery: a nationwide cohort study in South Korea. [2023]The optimal anesthetic technique for cancer surgery remains a controversial issue. This study aimed to examine whether propofol-based total intravenous anesthesia (TIVA) was associated with survival outcomes after major cancer surgery in South Korea and compare its effectiveness with that of inhalation anesthesia.
Impact of Propofol-based Total Intravenous Anesthesia Versus Inhalation Anesthesia on Long-term Survival After Cancer Surgery in a Nationwide Cohort. [2023]To compare the impact of propofol-based total intravenous anesthesia (TIVA) versus inhalational anesthesia (IA) on the overall survival following cancer surgery.
Propofol-Based Total Intravenous Anesthesia is Associated with Better Survival than Desflurane Anesthesia in Epithelial Ovarian Cancer Surgery: A Retrospective Cohort Study. [2021]Background: Previous studies have shown that anesthetic techniques can affect outcomes of cancer surgery. We investigated the association between anesthetic techniques and patient outcomes after elective epithelial ovarian cancer surgery. Methods: This was a retrospective cohort study of patients who received elective open surgery for epithelial ovarian cancer between January 2009 and December 2014. Patients were grouped according to the administration of propofol or desflurane anesthesia. Kaplan-Meier analysis was performed, and survival curves were constructed from the date of surgery to death. Univariate and multivariate Cox regression models were used to compare hazard ratios for death after propensity matching. Subgroup analyses were performed for age, body mass index, preoperative carbohydrate antigen-125 level, International Federation of Gynecology and Obstetrics staging, and operation and anesthesia time. Results: In total, 165 patients (76 deaths, 46.1%) who received desflurane anesthesia and 119 (30 deaths, 25.2%) who received propofol anesthesia were eligible for analysis. After propensity matching, 104 patients were included in each group. In the matched analysis, patients who received propofol anesthesia had better survival with a hazard ratio of 0.52 (95% confidence interval, 0.33-0.81; p = 0.005). Subgroup analyses also showed significantly better survival with old age, high body mass index, elevated carbohydrate antigen-125 level, advanced International Federation of Gynecology and Obstetrics stage, and prolonged operation and anesthesia time in the matched propofol group. In addition, patients administered with propofol anesthesia had less postoperative recurrence and metastasis than those administered with desflurane anesthesia in the matched analysis. Conclusion: Propofol anesthesia was associated with better survival in patients who underwent elective epithelial ovarian cancer open surgery. Prospective studies are warranted to evaluate the effects of propofol anesthesia on oncological outcomes in patients with epithelial ovarian cancer.