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

NCT05286697 | Completed

• 1 other identifier: 09.2021.1035
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Pressure Increase; Postoperative Cognitive Dysfunction

Keywords

laparoscopic hysterectomy; trendelenburg position; optic nerve sheath diameter (ONSD); Mini Mental State Examination (MMSE); postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• Optic nerve diameter measurement

  all patients' Optic nerve diameter will be measured by the same experienced anesthetist and recorded

  Intraoperative

Secondary Outcomes (1)

• mini mental test

  Baseline (before surgery) and immediately after surgery.

Study Arms (1)

effect of increase intracranial pressure on postoperatve cognitive function

OTHER

All patient will be given a mini mental test before and after the surgery and the optic nerve diameter will be measured 5 times during the surgery.

Diagnostic Test: measuring optic nerve diameter

Interventions

measuring optic nerve diameter DIAGNOSTIC_TEST

During the measurement of the 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.

effect of increase intracranial pressure on postoperatve cognitive function

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 2-3,
• Patients aged 30-75 years who are scheduled for laparoscopic hysterectomy will be included.

You may not qualify if:

• Patients with a previous history of ocular disease,
• undergoing ocular surgery,
• patients with neurological disease and transient ischemic attack,
• Cases who converted to open surgery will be excluded from the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• MELIHA ORHON ERGUN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 18, 2022
• Study Start: March 15, 2022
• Primary Completion: March 28, 2022
• Study Completion: April 19, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)