RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-11-10
Study Completion:2027-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04281017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females ≥ eighteen years of age
  2. * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
  3. * 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must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer)
  4. * Subjects must be cleared for surgery by the pre-anesthesia clinic
  5. * All robotic GYN cancer patients 18 years of age and older with any preexisting medical conditions that are deemed ready for surgery by the pre anesthesia clinic
  1. * Known increased intraocular pressure, prior eye surgery within a month, eye conditions where the ophthalmologist would not allow an intra ocular pressure measurement
  2. * Subjects with a previous treatment of diagnosis of increased intraocular pressure
  3. * Subjects who have undergone eye surgery in the 30 days prior to consent
  4. * Subjects for whom an ophthalmologist has determined cannot undergo intraocular pressure measurement

Contacts and Locations

Study Contact

Sonia Mehta, MD
CONTACT
352-273-7094
sdeshmukh@anest.ufl.edu
Anna Woods
CONTACT
352-294-8345
awoods@anest.ufl.edu

Principal Investigator

Sonia Mehta, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Sonia Mehta, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-10
Study Completion Date2027-06-18

Study Record Updates

Study Start Date2020-11-10
Study Completion Date2027-06-18

Terms related to this study

Keywords Provided by Researchers

  • robotic gynecologic surgery

Additional Relevant MeSH Terms

  • Intraocular Pressure
  • Oncology