The Effect of the Steep Trendelenburg Position on Intraocular Pressure

Intraocular Pressure Clinical Trial

Official title:

The Effect of the Steep Trendelenburg Position on Intraocular Pressure ın Patients Undergoing Total Laparoscopic Hysterectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440642
• Other study ID #: 2023/51,1/250/33
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: Irem DURMUS, MD, Specialist
• Phone: 05449306949
• Email: irem.durmus89[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This study is planned to be conducted in the operating room of Kartal Dr. Lütfi Kırdar City Hospital between June 2024 and July 2024. A total of 50 patients aged between 18-60 years, classified as ASA I-II, undergoing elective total laparoscopic hysterectomy in the steep Trendelenburg position will be included in the study. Patients who are under 18 years or over 60 years, classified as ASA III or above, or have pre-existing eye conditions causing intraocular pressure changes such as glaucoma or ocular hypertension, cranial tumors, or any conditions that may be affected by increased intracranial pressure will not be included in the study.

All patients will undergo a preoperative evaluation the day before surgery, and written informed consent will be obtained for participation in the study. Patients who agree to participate will have an eye examination performed by an ophthalmologist preoperatively. Intraocular pressure (IOP) 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).

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The anesthesia protocol will be standardized for the drugs used during the procedure. Standard anesthesia induction will be provided with 2 mg IV midazolam, 3 mg/kg IV propofol, 100 mcg IV fentanyl, and 0.8 mg/kg IV rocuronium. Sevoflurane at 1 Minimum Alveolar Concentration (MAC) will be used for anesthesia maintenance. While the patient is in the supine position, intraperitoneal CO2 insufflation will be used to create pneumoperitoneum. The patients will then be placed in the steep Trendelenburg position (25 degrees from horizontal) at the maximum Trendelenburg angle (STP). All procedures will be performed in the same operating room, on the same table, and at the same angle. Intraperitoneal pressure will be maintained at 15 mm Hg throughout the surgery. At the end of the operation, patients will be awakened and transferred to the recovery unit. In the recovery unit, patients will be monitored for at least 30 minutes.

Intraocular pressure (IOP) will be measured in the supine position using a contact handheld tonometer (TONO-PEN AVIA, Reichert, USA). The Tono-pen is chosen for its speed, the ability to measure across multiple patients with single-use latex tip covers, ease of use, accuracy, and reliability in various positions. Five consecutive measurements will be taken for each eye. If the variability between consecutive measurements exceeds 5%, the measurements will be repeated. The average of the five measurements will be taken for each measurement. All measurements will be performed by the same ophthalmologist. All surgical operations will be conducted in the morning or early afternoon to prevent diurnal variations in IOP. All surgeries will be performed by the same surgical team.

The demographic data of the patients and the durations of the operations will be recorded. IOP will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), when placed in STP (23° head down) (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). Simultaneously with IOP measurements, the patients' hemodynamic data (blood pressure, heart rate, end-tidal CO2, partial saturation) will be recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• electively laparoscopic hysterectomy surgery with steep trendelenburg position

• ASA I-II

• Between 18-60 years old

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intraocular Pressure
• Laparoscopic Surgery

Intervention

Device:
• tonopen
Intraoculer pressure will be measured in the supine position after intubation (T1), during pneumoperitoneum (T2), when placed in steep trendelenburg position (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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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