Effect of Position & Anesthetic Choice in Intraocular Pressure in Robotic

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

During the day of surgery, the anesthesiologist trained by an ophthalmologist, will measure each eye's Intraocular Pressure (IOP) using a tonometer for both the Trendelenburg with IV anesthetics (TIVA) and propofol/fentanyl/rocuronium arms of the study. (The Tono-Pen XL Medtronic Solan, Jacksonville, FL) The Intraocular Pressure (IOP) for both eyes will be measured at seven time points: Time 1 induction after administration of sedative and local anesthesia in the eye. Both eyes of the patient will anesthetized using topical proparacaine hydrochloride ophthalmic solution 0.5%. Time 2 Post induction table 0 degrees Time 3 Supine after pneumoperitoneum with 14 mmHg pressure Time 4 After docking robot at correct Trendelenburg positioned measured by a level Time 5 After undocking and before moving supine Time 6 Supine and before extubation. If the intraocular pressure remains elevated above 19 mmHg will require a 7th measurement in PACU with HOB at 30 degrees and if the pressure still at or above 19 ophthalmology consult initiated. Time 7 if needed, see above If the patient has any increased reading at the end of the procedure, the same attending anesthesiologist in the post-operative recovery area prior to discharge will do a post op measurement. Any abnormal readings will prompt an ophthalmology consult and follow up with ophthalmology department. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04281017
Study type	Interventional
Source	University of Florida
Contact	Sonia Mehta, MD
Phone	352-273-7094
Email	sdeshmukh@anest.ufl.edu
Status	Recruiting
Phase	Phase 4
Start date	November 10, 2020
Completion date	July 20, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01439152` - Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.	Phase 1
Recruiting	`NCT05615246` - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Active, not recruiting	`NCT06015009` - Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers	N/A
Active, not recruiting	`NCT03298100` - Risk Scoring Model for Endometrial Cancer
Recruiting	`NCT05055609` - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors	Phase 1
Not yet recruiting	`NCT04324320` - Psychological Distress in Outpatient Oncological Rehabilitation
Completed	`NCT00588289` - Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA	N/A
Recruiting	`NCT06222801` - The 1st Tumor CytokinoTherapy Database (TCTD-1)
Recruiting	`NCT03831633` - Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients	Phase 4
Completed	`NCT04914702` - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting	`NCT05198570` - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Recruiting	`NCT05712174` - A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer	Phase 2
Recruiting	`NCT03832062` - Value of Analysing Under-utilised Leftover Tissue (VauLT)
Completed	`NCT03988777` - Magnetic Seed Localisation for Nonpalpable Breast Lesions
Recruiting	`NCT06031233` - Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie	Phase 4
Enrolling by invitation	`NCT04019119` - Digital Intervention for the Modification of Lifestyles (iGame)	N/A
Not yet recruiting	`NCT05926362` - Capillary-Venous Paired Data Collection
Recruiting	`NCT05510856` - Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients	Phase 4
Recruiting	`NCT05686213` - ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial	Phase 2
Completed	`NCT04180306` - PEWS Implementation in an LMIC Setting	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms