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General Anesthetic

Anesthesia Choice for Gynecologic Cancer Surgery

Phase 4
Recruiting
Led By Nelson Algarra, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be cleared for surgery by the pre-anesthesia clinic
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery
Awards & highlights

Study Summary

This trial is testing whether total IV anesthesia decreases intraocular pressure during robotic cancer surgery in the Trendelenburg position.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed, general risks may include typical anesthesia reactions such as nausea, drowsiness post-surgery, sore throat from breathing tubes, and less commonly, more serious complications like allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been cleared for surgery by the anesthesia team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantify the degree of change in intra ocular pressure in female patients undergoing robotic procedures

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TIVA
2019
Completed Phase 4
~400

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,351 Previous Clinical Trials
722,150 Total Patients Enrolled
Nelson Algarra, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
90 Total Patients Enrolled
Sonia Mehta, MDPrincipal InvestigatorUniversity of Florida

Media Library

Balanced anesthesia (General Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04281017 — Phase 4
Cancer Research Study Groups: Balanced anesthesia, TIVA anesthesia
Cancer Clinical Trial 2023: Balanced anesthesia Highlights & Side Effects. Trial Name: NCT04281017 — Phase 4
Balanced anesthesia (General Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04281017 — Phase 4
~23 spots leftby Jul 2025
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