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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must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer)

Subjects must be cleared for surgery by the pre-anesthesia clinic

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

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

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I have been cleared for surgery by the anesthesia team.

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

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I am a woman aged 18 or older.

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

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,605 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current status of TIVA anesthesia according to federal regulations?

"There is ample evidence attesting to the safety of TIVA anesthesia, thus it earned a score of 3."

Answered by AI

Is my profile compatible with the requirements for this trial?

"Eligible patients for this trial must have a confirmed diagnosis of cancer and be between 18-99 years in age. The total number of enrollees is expected to approximate 100."

Answered by AI

Are octogenarians being accepted for involvement in this research project?

"The criteria for participation in this trial stipulate that candidates must be between 18 and 99 years of age. For those younger than 18, there are 301 studies available while 2211 trials exist for individuals aged 65 or older."

Answered by AI

Is enrolment into this research still possible for interested individuals?

"Yes, current information from clinicaltrials.gov confirms that enrolment for this medical trial is still open and active. It was first posted on November 10th 2020 and it's looking to recruit 100 patients at 1 location."

Answered by AI

What is the total capacity for participation in this clinical research?

"Affirmative. According to information displayed on clinicaltrials.gov, this study is currently seeking participants. It was initially posted on November 10th 2020 and the latest revision occurred October 26th 2022. 100 patients need to be recruited from one medical centre for it to be successful."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients

2020. "Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04281017.

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