The Effect of the Steep Trendelenburg Position on Intraocular Pressure

NCT06440642 | Completed

• 1 other identifier: 2023/51,1/250/33
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 50 patients aged between 18-60 years, classified as American Society of Anesthesiologists (ASA) I-II, undergoing elective total laparoscopic hysterectomy in the steep trendelenburg position (STP) will be included in the study. Preoperatively, an ophthalmologist will perform an eye examination on the patients, and intraocular pressure will be measured using a non-contact computerized tonometer (Topcon CT-800, Japan). Central corneal thickness and iridocorneal angle will be measured using a topography device (Sirius Topography, CSO, Italy), and the thickness of the retinal nerve fiber layer (RNFL) will be measured using an optical coherence tomography (OCT) device (DRI OCT Triton, Topcon, Japan). Patients' demographic data and operation durations will be recorded. Intraocular pressure (IOP) will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), in the steep Trendelenburg position (23°, head down) (T3), at the end of the operation when pneumoperitoneum is terminated (T4), after returning to the supine position (T5), and 10 minutes after returning to the supine position (T6). Simultaneously with IOP measurements, the patients' hemodynamic data (Blood pressure, heart rate, end-tidal CO2, partial saturation) will be recorded.

Conditions

Laparoscopic Surgery; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Evaluate patients' intraoculer pressure

  the primary aim of the study is to evaluate patients' intraoculer pressure change during laparoscopic hysterectomy, position of steep trendelenburg

  during surgery and 10 minutes after the end of the operation

Study Arms (1)

steep trendelenburg

Patients Undergoing Laparoscopic Hysterectomy

Device: tonopen

Interventions

tonopen DEVICE

Intraoculer pressure will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), when placed in steep trendelenburg posıtıon (T3), at the end of the operation when pneumoperitoneum is terminated (T4), after being placed back in the supine position (T5), and 10 minutes after being placed back in the supine position (T6).

steep trendelenburg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 50 patients aged between 18 and 60 years with ASA I-II who will undergo elective total laparoscopic hysterectomy in the steep trendelenburg position.

You may qualify if:

• electively laparoscopic hysterectomy surgery with steep trendelenburg position
• ASA I-II
• Between 18-60 years old

You may not qualify if:

• Those under 18 or over 60 years old,
• ASA III and above,
• pre-existing eye conditions such as glaucoma, ocular hypertension, or other conditions affecting intraocular pressure
• those with conditions such as cranial tumors

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr Lütfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 4, 2024
• Study Start: June 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

TU (1)