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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

Must not have

Subjects with a previous treatment of diagnosis of increased intraocular pressure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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I have been cleared for surgery by the anesthesia team.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quantify the degree of change in intra ocular pressure in female patients undergoing robotic procedures

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~460

0 / 2Eligibility criteria met