Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440642
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-05-23
Brief Title:
The Effect of the Steep Trendelenburg Position on Intraocular Pressure
Sponsor:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Organization:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Study Overview
Official Title:
The Effect of the Steep Trendelenburg Position on Intraocular Pressure ın Patients Undergoing Total Laparoscopic Hysterectomy
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Sure here is the translation of your text into English
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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 mgkg IV propofol 100 mcg IV fentanyl and 08 mgkg 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
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
Sure here is the translation of your text into English
---
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 mgkg IV propofol 100 mcg IV fentanyl and 08 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None