NCT05286697

The Effect of Optic Nerve Diameter on Postoperative Cognitive Function in Laparoscopic Hysterectomy

Completed NA Last updated 21 April 2022

What this trial tests

NA trial testing measuring optic nerve diameter in Intracranial Pressure Increase in 40 participants. Completed in 19 April 2022.

Timeline

15 March 2022

Primary endpoint
28 March 2022

19 April 2022

Quick facts

Lead sponsor	Marmara University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	40
Start date	15 March 2022
Primary completion	28 March 2022
Estimated completion	19 April 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• measuring optic nerve diameter

Conditions studied

• Intracranial Pressure Increase — all drugs for Intracranial Pressure Increase →
• Postoperative Cognitive Dysfunction — all drugs for Postoperative Cognitive Dysfunction →

Sponsor

Marmara University

Who can join

Adults 30 to 75, female only, with Intracranial Pressure Increase or Postoperative Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prospective study, 40 patients ASA 2-3, 30-75 years old who were planned for laparoscopic hysterectomy operation will be included.One day before the operation and postoperative 1.3.7. A mini mental assessment test will be performed on these days.Standard monitoring and Near-Infrared Spectroscopy monitoring to measure cerebral oxygen saturation will be performed on the patients.NIRS sensors will be placed on the right and left sides of the forehead, 2 cm above the eyebrow, before induction of anesthesia. Before the induction of anesthesia, the measurement will begin and the FiO2 (fraction of inspiration oxygen) will be kept at 60%.General anesthesia induction will be made with propofol 2mg/kg, remifentanil 0.5 µg/kg and rocuronium 0.6mg/kg, and maintenance will be provided with 2% sevoflurane.The patient will be intubated and ventilation support will be provided so that the tidal volume is 6-8 ml/kg and the end tidal CO2 is 30-40 mmHg. PEEP (Positive end expiratory pressure) will not be applied to any patient. Intra-abdominal pressure will be maintained at 15 mmHg. All patients will be given 1gr paracetamol and 100mg tramadol for postoperative analgesia.During the measurement of optic nerve diameter, a layer of sterile water-soluble gel will be applied on the closed eyelid with a linear 10-5 MHz ultrasound probe. In our study, ONSDs of all patients will be measured by the same experienced anesthetist. Measurements will be made at 5 different times. 5 minutes after induction of anesthesia in the supine position (T0), 5 minutes after the onset of pneumoperitoneum (T1), 5 minutes after the upright trendelenburg position (T2), at the 2nd hour of the trendelenburg position (T3) and 5 minutes after returning to the supine position at the end of the surgery (T4) .ONSD measurements of the patients measured at 5 different times, peroperative NIRS values, peroperative SpO2, mean blood pressure, peak heart rate, anesthesia time, surgery time, time to stay in the trendelenburg position, partial oxygen saturation (PaO2), PCO2, end-tidal carbon dioxide (ETCO2) and peak airway pressure (pPEAK) will be recorded.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.