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Laparoscopic SurgeryNCT06440642

The Effect of the Steep Trendelenburg Position on Intraocular Pressure

An observational study of Laparoscopic Surgery and Intraocular Pressure, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Laparoscopic Surgery, Intraocular Pressure
What is being tested?
tonopen
Type of treatment
Medical device
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2024to 31 Jul 2024
How long will I take part?
2 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kartal Dr Lütfi Kirdar City Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed 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.

Being tested
tonopen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tonopenDevice

    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).

Study groups in NCT06440642
Study groupRoleWhat they receive
steep trendelenburgPatients Undergoing Laparoscopic Hysterectomy
Receives: Device: tonopen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: during surgery and 10 minutes after the end of the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start1 Jun 2024
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
50 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06440642
Sponsor's protocol ID
2023/51,1/250/33
Status last verified
Aug 2024
First submitted
23 May 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Laparoscopic Surgery and Intraocular Pressure, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate patients' intraoculer pressure (time frame: during surgery and 10 minutes after the end of the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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