This phase IV trial examines the effects two different anesthesia approaches (total intravenous anesthesia [TIVA] versus balanced anesthesia) have on the pressure within the eyeball (intraocular) during robotic surgery for gynecologic cancers. Patients who are undergoing gynecologic surgeries are often put in a position called the steep Trendelenburg position, in which the patient is angled at around 45 degrees in the head-down position. This positioning has been shown to increase intraocular pressure, which can lead to temporary or even permanent vision changes. Anesthetic drugs such as propofol, fentanyl, rocuronium, isoflurane, lidocaine, and ketamine are used to induce a loss of feeling and/or consciousness to prevent patients from feeling pain. Different anesthetic techniques have been shown to alter intraocular pressure. Anesthesia delivered exclusively via a vein (intravenously) (TIVA) has been shown to have more favorable effects on intraocular pressure as opposed to anesthesia techniques that use both intravenous and inhaled approaches (balanced anesthesia). Currently, all gynecological robotic surgeries use the balanced approach. The use of TIVA during surgery may be effective at protecting patients from changes in intraocular pressure during gynecologic surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT04281017.
Locations matching your search criteria
United States
Florida
Gainesville
University of Florida Health Science Center - GainesvilleStatus: Active
Contact: Sonia D. Mehta
Phone: 352-273-7094
PRIMARY OBJECTIVE:
I. To examine the relationship between anesthesia approach (i.e., TIVA anesthesia or balanced anesthesia) and intraocular pressure during robotic surgery for gynecological cancers.
SECONDARY OBJECTIVES:
I. To examine rate of abnormal intraocular pressure associated with total intravenous anesthesia as compared with a balanced approach.
II. To build a model to examine rate of abnormal intraocular pressure in subjects with different pre-existing conditions and surgical variables, including length of procedure, pre-existing conditions and anesthesia type.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (BALANCED ANESTHESIA): Patients receive propofol intravenously (IV), fentanyl IV, and rocuronium IV for anesthetic induction prior to surgery. During surgery, patients receive isoflurane via inhalation for anesthetic maintenance. Patients also undergo tonometry during surgery.
ARM II (TIVA): Patients receive propofol IV, fentanyl IV, and rocuronium IV for anesthetic induction prior to surgery. During surgery, patients receive propofol IV, lidocaine IV, and ketamine IV for anesthetic maintenance. Patients also undergo tonometry during surgery.
After completion of study intervention, patients are followed up within 60 days.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationUniversity of Florida Health Science Center - Gainesville
Principal InvestigatorSonia D. Mehta
